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GMVs in Primary Care: An RCT of Group-Based Versus Individual Appointments to Reduce HbA1c in Older People (GAP)

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ClinicalTrials.gov Identifier: NCT02002143
Recruitment Status : Recruiting
First Posted : December 5, 2013
Last Update Posted : November 22, 2017
Sponsor:
Collaborator:
Ministry of Health, British Columbia
Information provided by (Responsible Party):
Karim Miran-Khan, University of British Columbia

Brief Summary:

Type 2 diabetes is a major problem of older people; its prevalence is greater than 20% in those aged over 65 years. Treatment such as medication, healthy nutritional choices & body weight management, as well as physical activity can reduce the impact of diabetes.

Older patients with type 2 diabetes can potentially benefit from Group Appointments, in which 8-12 patients share one appointment of about 60-120 minutes with a team of health professionals.

The team of investigators (3 people) will see the 'Group' 4 times/yr for two years. Their key measure of success will be control of glycosylated hemoglobin - HbA1C.

To address their primary and secondary research objectives the investigators will focus upon patients aged 65 years or older who have T2DM and who are being treated with oral hypoglycemic agents and diet, or diet alone.

The investigators will compare patients randomized to (A) eight Group Appointments over a 24 month period (i.e., 4 per year), led by a primary care physician [Intervention] with, (B) patients randomized to eight traditional one-to-one usual care appointments also provided by a primary care physician (Individual Appointment; [Control]). The investigators will compare (A) and (B) on selected clinical, patient-rated, and economic outcome measures.

SIGNIFICANCE: Seven Canadian provinces already have Group Appointment billing codes for physicians who lead Group Appointments. If the study's proposed health care innovation demonstrates benefits, it would be possible to 'roll out' / 'scale up' the model province- or nation-wide in Primary Care settings.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus (T2DM) Behavioral: Group Appointments Behavioral: Individual Appointments (IAs) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Group Medical Visits (GMVs) in Primary Care: An RCT of Group-Based Versus Individual Appointments to Reduce HbA1c in Older People
Study Start Date : January 2014
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Individual Appointments (IAs)
Participants randomly assigned to the "IAs" group will receive eight traditional 1-to-1 appointments, seeing their physician quarterly as per standard care in BC. They will be referred to ancillary services such as nutrition advice, counseling, and physical activity promotion according to 'usual care' practice. In addition, we will organize 4 1-hour social events for these participants annually. The 4 social events will be 1) a potluck lunch; 2) a movie night; 3) an event chosen by participants; and 4) a talent show. From our experience, these events enhance compliance to reporting and minimize dropouts. These events also serve to minimize 'socialization bias' that may otherwise potentially influence health measures including quality of life.
Behavioral: Individual Appointments (IAs)
Participants randomly assigned to the "IAs" group will receive eight traditional 1-to-1 appointments, seeing their physician quarterly as per standard care in BC. They will be referred to ancillary services such as nutrition advice, counseling, and physical activity promotion according to 'usual care' practice. In addition, we will organize 4 1-hour social events for these participants annually. The 4 social events will be 1) a potluck lunch; 2) a movie night; 3) an event chosen by participants; and 4) a talent show. From our experience, these events enhance compliance to reporting and minimize dropouts. These events also serve to minimize 'socialization bias' that may otherwise potentially influence health measures including quality of life.

Experimental: Group Appointments (GAs)

Participants randomly assigned to the intervention group will participate in GAs of 8 patients for 1.5 hours, every 3 months for 2 years. The 3-member Care Team (MD, nurse, behaviorist) will attend each session. The nurse facilitates the session and curriculum. The MD responds to specific health questions. Patients may schedule time before or after to review their clinical results with the MD/nurse (e.g. HbAIC).

Key elements include 1) completed pre-appt questionnaires used to identify a patient's educational needs; 2) patients use goal setting and action plans to initiate and maintain healthy behaviors; 3) each class has a designated purpose and learning objectives; 4) sessional feedback, which is used to adapt the next class (3 months later) based on patient needs.

Behavioral: Group Appointments

Participants randomly assigned to the intervention group will participate in GAs of 8 patients for 1.5 hours, every 3 months for 2 years. The 3-member Care Team (MD, nurse, behaviorist) will attend each session. The nurse facilitates the session and curriculum. The MD responds to specific health questions. Patients may schedule time before or after to review their clinical results with the MD/nurse (e.g. HbAIC).

Key elements include 1) completed pre-appt questionnaires used to identify a patient's educational needs; 2) patients use goal setting and action plans to initiate and maintain healthy behaviors; 3) each class has a designated purpose and learning objectives; 4) sessional feedback, which is used to adapt the next class (3 months later) based on patient needs.

Other Names:
  • Shared Appointments
  • Group Medical Visits




Primary Outcome Measures :
  1. Patients' control (decreased levels) of HemoglobinA1C (clinical) [ Time Frame: Changes from baseline at 24 months ]
    The investigators will measure Hemoglobin A1C (%, primary outcome), utilizing the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.


Secondary Outcome Measures :
  1. Resting systolic blood pressure (mmHg)) (clinical) [ Time Frame: Changes from baseline at 12 months ]
    The investigators will assess resting systolic blood pressure with an automated BP device BPTRU™.

  2. Resting systolic blood pressure (mmHg)) (clinical) [ Time Frame: Changes from baseline at 24 months ]
    The investigators will assess resting systolic blood pressure with an automated BP device BPTRU™.

  3. Resting systolic blood pressure (mmHg)) (clinical) [ Time Frame: Changes from baseline at 36 months (1-year post-intervention) ]
    The investigators will assess resting systolic blood pressure with an automated BP device BPTRU™.

  4. Resting diastolic blood pressure (mmHg)) (clinical) [ Time Frame: Changes from baseline at 12 months ]
    The investigators will assess resting diastolic blood pressure with an automated BP device BPTRU™.

  5. Resting diastolic blood pressure (mmHg)) (clinical) [ Time Frame: Changes from baseline at 24 months ]
    The investigators will assess resting diastolic blood pressure with an automated BP device BPTRU™.

  6. Resting diastolic blood pressure (mmHg)) (clinical) [ Time Frame: Changes from baseline at 36 months (1-year post-intervention) ]
    The investigators will assess resting diastolic blood pressure with an automated BP device BPTRU™.

  7. Electrical activity of the heart (ECG) (clinical) [ Time Frame: Changes from baseline at 12 months ]
    The investigators will assess cardiovascular disease risk factors by 12-lead ECG (10 minutes).

  8. Electrical activity of the heart (ECG) (clinical) [ Time Frame: Changes from baseline at 24 months ]
    The investigators will assess cardiovascular disease risk factors by 12-lead ECG (10 minutes).

  9. Electrical activity of the heart (ECG) (clinical) [ Time Frame: Changes from baseline at 36 months (1-year post-intervention) ]
    The investigators will assess cardiovascular disease risk factors by 12-lead ECG (10 minutes).

  10. C-reactive protein (mg/L) (clinical) [ Time Frame: Changes from baseline at 12 months ]
    The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.

  11. C-reactive protein (mg/L) (clinical) [ Time Frame: Changes from baseline at 24 months ]
    The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.

  12. C-reactive protein (mg/L) (clinical) [ Time Frame: Changes from baseline at 36 months (1-year post-intervention) ]
    The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.

  13. plasma glucose (mmol/L) (clinical) [ Time Frame: Changes from baseline at 12 months ]
    The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.

  14. plasma glucose (mmol/L) (clinical) [ Time Frame: Changes from baseline at 24 months ]
    The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.

  15. plasma glucose (mmol/L) (clinical) [ Time Frame: Changes from baseline at 36 months (1-year post-intervention) ]
    The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.

  16. High-density lipoprotein - cholesterol (HDL-C; mmol/L) (clinical) [ Time Frame: Changes from baseline at 12 months ]
    The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.

  17. High-density lipoprotein - cholesterol (HDL-C; mmol/L) (clinical) [ Time Frame: Changes from baseline at 24 months ]
    The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.

  18. High-density lipoprotein - cholesterol (HDL-C; mmol/L) (clinical) [ Time Frame: Changes from baseline at 36 months (1-year post-intervention) ]
    The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.

  19. Fasting low-density lipoprotein (LDL; mmol/L) (clinical) [ Time Frame: Changes from baseline at 12 months ]
    The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.

  20. Fasting low-density lipoprotein (LDL; mmol/L) (clinical) [ Time Frame: Changes from baseline at 24 months ]
    The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.

  21. Fasting low-density lipoprotein (LDL; mmol/L) (clinical) [ Time Frame: Changes from baseline at 36 months (1-year post-intervention) ]
    The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.

  22. Triglycerides (mmol/L) (clinical) [ Time Frame: Changes from baseline at 12 months ]
    The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.

  23. Triglycerides (mmol/L) (clinical) [ Time Frame: Changes from baseline at 24 months ]
    The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.

  24. Triglycerides (mmol/L) (clinical) [ Time Frame: Changes from baseline at 36 months (1-year post-intervention) ]
    The investigators will utilize the phlebotomy unit in the CHHM Mobile Lab to collect a non-fasting blood sample (standard techniques). They will request that study participants not engage in any physical activity, or consume alcohol/caffeine 24 hours prior to measurement. Collected samples will be refrigerated in the Mobile Lab and transported the same day to the Vancouver General Hospital Pathology Lab for analysis as per current standard methods.

  25. Height (cm), weight (kg), waist & hip circumference (cm), fat and muscle mass (g) (clinical) [ Time Frame: Changes from baseline at 12 months ]
    Height (cm): The investigators will use the wall-mounted stadiometer (Rosscraft Inc). Weight (kg): Participants remove shoes and stand on an electronic scale (Seca Model 242, Hanover, MD). For height and weight, duplicate measures are taken unless measures differ by ±0.4 cm or ±0.2 kg, when a third measure is taken. The investigators will calculate body mass index (BMI) as wt/ht2. Waist circumference (cm): The investigators use a flexible steel tape. In older adults, it is most convenient to measure at the umbilical level. The investigators obtain two measures during minimal respiration and record to the nearest 0.1 cm. They perform a third measure if the difference between the first two measures is greater than 0.2 cm. The investigators use the mean of two and the median of three measurements for analysis for all measures. Fat and muscle mass (g): The investigators will assess total body fat mass (g) and muscle mass (g) by DXA (Hologic QDR 4500W,Hologic Inc., Waltham, MA).

  26. Height (cm), weight (kg), waist & hip circumference (cm), fat and muscle mass (g) (clinical) [ Time Frame: Changes from baseline at 24 months ]
    Height (cm): The investigators will use the wall-mounted stadiometer (Rosscraft Inc). Weight (kg): Participants remove shoes and stand on an electronic scale (Seca Model 242, Hanover, MD). For height and weight, duplicate measures are taken unless measures differ by ±0.4 cm or ±0.2 kg, when a third measure is taken. The investigators will calculate body mass index (BMI) as wt/ht2. Waist circumference (cm): The investigators use a flexible steel tape. In older adults, it is most convenient to measure at the umbilical level. The investigators obtain two measures during minimal respiration and record to the nearest 0.1 cm. They perform a third measure if the difference between the first two measures is greater than 0.2 cm. The investigators use the mean of two and the median of three measurements for analysis for all measures. Fat and muscle mass (g): The investigators will assess total body fat mass (g) and muscle mass (g) by DXA (Hologic QDR 4500W,Hologic Inc., Waltham, MA).

  27. Height (cm), weight (kg), waist & hip circumference (cm), fat and muscle mass (g) (clinical) [ Time Frame: Changes from baseline at 36 months (1-year post-intervention) ]
    Height (cm): The investigators will use the wall-mounted stadiometer (Rosscraft Inc). Weight (kg): Participants remove shoes and stand on an electronic scale (Seca Model 242, Hanover, MD). For height and weight, duplicate measures are taken unless measures differ by ±0.4 cm or ±0.2 kg, when a third measure is taken. The investigators will calculate body mass index (BMI) as wt/ht2. Waist circumference (cm): The investigators use a flexible steel tape. In older adults, it is most convenient to measure at the umbilical level. The investigators obtain two measures during minimal respiration and record to the nearest 0.1 cm. They perform a third measure if the difference between the first two measures is greater than 0.2 cm. The investigators use the mean of two and the median of three measurements for analysis for all measures. Fat and muscle mass (g): The investigators will assess total body fat mass (g) and muscle mass (g) by DXA (Hologic QDR 4500W,Hologic Inc., Waltham, MA).

  28. Quality of life (as measured by the health state utility values of EQ-5D3L questionnaire (patient-reported quality of life/economic)) [ Time Frame: Changes from baseline at 12 months ]
    QALYs are calculated based on the quality of life of a patient (measured using health utilities) in a given health state and the time spent in that health state. The EQ-5D enables QALYs to be estimated. This captures the gains from reduced morbidity and reduced mortality by assigning quality weights at specific time points to an intervention that are based on preferences, anchored on perfect health and death, and measured on an interval scale. Economic analyses will be conducted from the BC Ministry of Health perspective and will capture the time horizon of the trial (24 months).

  29. Quality of life (as measured by the health state utility values of EQ-5D3L questionnaire (patient-reported quality of life/economic)) [ Time Frame: Changes from baseline at 24 months ]
    QALYs are calculated based on the quality of life of a patient (measured using health utilities) in a given health state and the time spent in that health state. The EQ-5D enables QALYs to be estimated. This captures the gains from reduced morbidity and reduced mortality by assigning quality weights at specific time points to an intervention that are based on preferences, anchored on perfect health and death, and measured on an interval scale. Economic analyses will be conducted from the BC Ministry of Health perspective and will capture the time horizon of the trial (24 months).

  30. Quality of life (as measured by the health state utility values of EQ-5D3L questionnaire (patient-reported quality of life/economic)) [ Time Frame: Changes from baseline at 36 months (1-year post-intervention) ]
    QALYs are calculated based on the quality of life of a patient (measured using health utilities) in a given health state and the time spent in that health state. The EQ-5D enables QALYs to be estimated. This captures the gains from reduced morbidity and reduced mortality by assigning quality weights at specific time points to an intervention that are based on preferences, anchored on perfect health and death, and measured on an interval scale. Economic analyses will be conducted from the BC Ministry of Health perspective and will capture the time horizon of the trial (24 months).

  31. Health Care Utilization [ Time Frame: Changes from baseline at 12 months ]

    The investigators' economic evaluation will examine the incremental costs and benefits generated by using the Group Medical Appointments intervention versus usual care. The outcome of their cost utility analysis is the incremental cost effectiveness ratio (ICER).

    By definition, an ICER is the difference between the mean costs of providing the competing interventions divided by the difference in effectiveness (i.e., QALYs), where the ICER = Δ Cost / Δ Effect. Dr. Marra will conduct a prospective economic evaluation alongside the clinical trial to 1) estimate the mean/participant and total health care resource utilization and costs associated with Group Appointments and usual care; 2) determine the QoL as measured by health state utility values; and 3) conduct a cost-utility analysis. The cost-utility analysis will be assessed in terms of incremental cost per quality adjusted life year (QALY).

    Our instruments are the EQ-5D-3L and Heath Resource Utilization (HRU) questionnaires.


  32. Health Care Utilization [ Time Frame: Changes from baseline at 24 months ]

    The investigators' economic evaluation will examine the incremental costs and benefits generated by using the Group Medical Appointments intervention versus usual care. The outcome of their cost utility analysis is the incremental cost effectiveness ratio (ICER).

    By definition, an ICER is the difference between the mean costs of providing the competing interventions divided by the difference in effectiveness (i.e., QALYs), where the ICER = Δ Cost / Δ Effect. Dr. Marra will conduct a prospective economic evaluation alongside the clinical trial to 1) estimate the mean/participant and total health care resource utilization and costs associated with Group Appointments and usual care; 2) determine the QoL as measured by health state utility values; and 3) conduct a cost-utility analysis. The cost-utility analysis will be assessed in terms of incremental cost per quality adjusted life year (QALY).

    Our instruments are the EQ-5D-3L and Heath Resource Utilization (HRU) questionnaires.


  33. Health Care Utilization [ Time Frame: Changes from baseline at 36 months (1-year post-intervention) ]

    The investigators' economic evaluation will examine the incremental costs and benefits generated by using the Group Medical Appointments intervention versus usual care. The outcome of their cost utility analysis is the incremental cost effectiveness ratio (ICER).

    By definition, an ICER is the difference between the mean costs of providing the competing interventions divided by the difference in effectiveness (i.e., QALYs), where the ICER = Δ Cost / Δ Effect. Dr. Marra will conduct a prospective economic evaluation alongside the clinical trial to 1) estimate the mean/participant and total health care resource utilization and costs associated with Group Appointments and usual care; 2) determine the QoL as measured by health state utility values; and 3) conduct a cost-utility analysis. The cost-utility analysis will be assessed in terms of incremental cost per quality adjusted life year (QALY).

    Our instruments are the EQ-5D-3L and Heath Resource Utilization (HRU) questionnaires.


  34. Anxiety [ Time Frame: Changes from baseline at 12 months ]

    The investigators will assess anxiety with the recommended Generalized Anxiety Disorder 7-item (GAD-7) scale. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for generalised anxiety disorder. It is moderately good at screening three other common anxiety disorders - panic disorder (sensitivity 74%, specificity 81%), social anxiety disorder (sensitivity 72%, specificity 80%), and post-traumatic stress disorder (sensitivity 66%, specificity 81%).

    The GAD-7 offer clinicians concise, self-administered screening and diagnostic tools for mental health disorders.


  35. Anxiety [ Time Frame: Changes from baseline at 24 months ]

    The investigators will assess anxiety with the recommended Generalized Anxiety Disorder 7-item (GAD-7) scale. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for generalised anxiety disorder. It is moderately good at screening three other common anxiety disorders - panic disorder (sensitivity 74%, specificity 81%), social anxiety disorder (sensitivity 72%, specificity 80%), and post-traumatic stress disorder (sensitivity 66%, specificity 81%).

    The GAD-7 offer clinicians concise, self-administered screening and diagnostic tools for mental health disorders.


  36. Anxiety [ Time Frame: Changes from baseline at 36 months (1-year post-intervention) ]

    The investigators will assess anxiety with the recommended Generalized Anxiety Disorder 7-item (GAD-7) scale. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for generalised anxiety disorder. It is moderately good at screening three other common anxiety disorders - panic disorder (sensitivity 74%, specificity 81%), social anxiety disorder (sensitivity 72%, specificity 80%), and post-traumatic stress disorder (sensitivity 66%, specificity 81%).

    The GAD-7 offer clinicians concise, self-administered screening and diagnostic tools for mental health disorders.


  37. Depression [ Time Frame: Changes from baseline at 12 months ]
    The investigators will assess depression with the recommended Geriatric Depression Scale (GDS). The GDS is a 30-item self-report assessment used to identify depression in the elderly. The scale was first developed in 1982 by J.A. Yesavage and others.

  38. Depression [ Time Frame: Changes from baseline at 24 months ]
    The investigators will assess depression with the recommended Geriatric Depression Scale (GDS). The GDS is a 30-item self-report assessment used to identify depression in the elderly. The scale was first developed in 1982 by J.A. Yesavage and others.

  39. Depression [ Time Frame: Changes from baseline at 36 months (1-year post-intervention) ]
    The investigators will assess depression with the recommended Geriatric Depression Scale (GDS). The GDS is a 30-item self-report assessment used to identify depression in the elderly. The scale was first developed in 1982 by J.A. Yesavage and others.

  40. Satisfaction With Life Scale [ Time Frame: Changes from baseline at 12 months ]
    The Satisfaction With Life Scale (SWLS) is a measure of life satisfaction developed by Ed Diener and colleagues (Diener, Emmons, Larsen & Griffin, 1985). The SWLS consists of 5-items that are completed by the individual whose life satisfaction is being measured.

  41. Satisfaction With Life Scale [ Time Frame: Changes from baseline at 24 months ]
    The Satisfaction With Life Scale (SWLS) is a measure of life satisfaction developed by Ed Diener and colleagues (Diener, Emmons, Larsen & Griffin, 1985). The SWLS consists of 5-items that are completed by the individual whose life satisfaction is being measured.

  42. Satisfaction With Life Scale [ Time Frame: Changes from baseline at 36 months (1-year post-intervention) ]
    The Satisfaction With Life Scale (SWLS) is a measure of life satisfaction developed by Ed Diener and colleagues (Diener, Emmons, Larsen & Griffin, 1985). The SWLS consists of 5-items that are completed by the individual whose life satisfaction is being measured.

  43. Physical Activity (PASE) [ Time Frame: Changes from baseline at 12 months ]
    The investigators will assess physical activity with the valid and reliable Physical Activities Scale for the Elderly (PASE) questionnaire. PASE was designed for those aged 65 years and older; participants use a 12-item scale to self-report the hours per day (average) spent participating in leisure, household, and occupational physical activities over the previous seven-day period. Physical activity is an important covariate in this study.

  44. Physical Activity (PASE) [ Time Frame: Changes from baseline at 24 months ]
    The investigators will assess physical activity with the valid and reliable Physical Activities Scale for the Elderly (PASE) questionnaire. PASE was designed for those aged 65 years and older; participants use a 12-item scale to self-report the hours per day (average) spent participating in leisure, household, and occupational physical activities over the previous seven-day period. Physical activity is an important covariate in this study.

  45. Physical Activity (PASE) [ Time Frame: Changes from baseline at 36 months (1-year post-intervention) ]
    The investigators will assess physical activity with the valid and reliable Physical Activities Scale for the Elderly (PASE) questionnaire. PASE was designed for those aged 65 years and older; participants use a 12-item scale to self-report the hours per day (average) spent participating in leisure, household, and occupational physical activities over the previous seven-day period. Physical activity is an important covariate in this study.

  46. Physical Activity (SenseWear) [ Time Frame: Changes from baseline at 12 months ]
    The investigators will assess physical activity with the valid and reliable SenseWear armband, measuring steps/per day, energy expenditure (calories), and hours of activity (METs (sedentary, moderate, vigorous, very vigorous)). Participants will wear the armband for seven consecutive days, including while sleeping.

  47. Physical Activity (SenseWear) [ Time Frame: Changes from baseline at 24 months ]
    The investigators will assess physical activity with the valid and reliable SenseWear armband, measuring steps/per day, energy expenditure (calories), and hours of activity (METs (sedentary, moderate, vigorous, very vigorous)). Participants will wear the armband for seven consecutive days, including while sleeping.

  48. Physical Activity (SenseWear) [ Time Frame: Changes from baseline at 36 months (1-year post-intervention) ]
    The investigators will assess physical activity with the valid and reliable SenseWear armband, measuring steps/per day, energy expenditure (calories), and hours of activity (METs (sedentary, moderate, vigorous, very vigorous)). Participants will wear the armband for seven consecutive days, including while sleeping.

  49. Goal Setting and Action Planning [ Time Frame: Baseline ]

    Behavioural principles underpinning the intervention: Assistant Professor and Canada Research Chair HOPPMANN leads the behavioural aspects of the study. From her experience in psychological aging research and everyday health behaviours she designs Group Appointments to help patients 1) set realistic health goals; 2) identify good opportunities to translate those health goals into action (action planning); and 3) proactively map out strategies that maintain health behaviours in the face of challenges (coping planning).

    The investigators will utilize a psychology / goal setting questionnaire.


  50. Goal Setting and Action Planning [ Time Frame: Changes from baseline at 12 months ]

    Behavioural principles underpinning the intervention: Assistant Professor and Canada Research Chair HOPPMANN leads the behavioural aspects of the study. From her experience in psychological aging research and everyday health behaviours she designs Group Appointments to help patients 1) set realistic health goals; 2) identify good opportunities to translate those health goals into action (action planning); and 3) proactively map out strategies that maintain health behaviours in the face of challenges (coping planning).

    The investigators will utilize a psychology / goal setting questionnaire.


  51. Goal Setting and Action Planning [ Time Frame: Changes from baseline at 24 months ]

    Behavioural principles underpinning the intervention: Assistant Professor and Canada Research Chair HOPPMANN leads the behavioural aspects of the study. From her experience in psychological aging research and everyday health behaviours she designs Group Appointments to help patients 1) set realistic health goals; 2) identify good opportunities to translate those health goals into action (action planning); and 3) proactively map out strategies that maintain health behaviours in the face of challenges (coping planning).

    The investigators will utilize a psychology / goal setting questionnaire.


  52. Goal Setting and Action Planning [ Time Frame: Changes from baseline at 36 months ]

    Behavioural principles underpinning the intervention: Assistant Professor and Canada Research Chair HOPPMANN leads the behavioural aspects of the study. From her experience in psychological aging research and everyday health behaviours she designs Group Appointments to help patients 1) set realistic health goals; 2) identify good opportunities to translate those health goals into action (action planning); and 3) proactively map out strategies that maintain health behaviours in the face of challenges (coping planning).

    The investigators will utilize a psychology / goal setting questionnaire.


  53. Food Diary [ Time Frame: Baseline ]
    Investigators will assess nutritional intake, using a three-day food diary.

  54. Food Diary [ Time Frame: Changes from baseline at 12 months ]
    Investigators will assess nutritional intake, using a three-day food diary.

  55. Food Diary [ Time Frame: Changes from baseline at 24 months ]
    Investigators will assess nutritional intake, using a three-day food diary.

  56. Food Diary [ Time Frame: Changes from baseline at 36 months (1-year post-intervention) ]
    Investigators will assess nutritional intake, using a three-day food diary.

  57. Patient Self-Management [ Time Frame: Baseline ]
    Investigators will assess patient self-management, using the Patient Activation Measure (PAM) questionnaire. Patient self-management has been identified as a key component to the management of T2DM (CDA/ADA Practice Guidelines). Patients who have the skills, ability, and willingness to manage their own health have better health outcomes. The PAM questionnaire has been tested extensively across a number of different languages, cultures, and demographic groups, and among people with different health conditions.

  58. Patient Self-Management [ Time Frame: Changes from baseline at 12 months ]
    Investigators will assess patient self-management, using the Patient Activation Measure (PAM) questionnaire. Patient self-management has been identified as a key component to the management of T2DM (CDA/ADA Practice Guidelines). Patients who have the skills, ability, and willingness to manage their own health have better health outcomes. The PAM questionnaire has been tested extensively across a number of different languages, cultures, and demographic groups, and among people with different health conditions.

  59. Patient Self-Management [ Time Frame: Changes from baseline at 24 months ]
    Investigators will assess patient self-management, using the Patient Activation Measure (PAM) questionnaire. Patient self-management has been identified as a key component to the management of T2DM (CDA/ADA Practice Guidelines). Patients who have the skills, ability, and willingness to manage their own health have better health outcomes. The PAM questionnaire has been tested extensively across a number of different languages, cultures, and demographic groups, and among people with different health conditions.

  60. Patient Self-Management [ Time Frame: Changes from baseline at 36 months (1-year post-intervention) ]
    Investigators will assess patient self-management, using the Patient Activation Measure (PAM) questionnaire. Patient self-management has been identified as a key component to the management of T2DM (CDA/ADA Practice Guidelines). Patients who have the skills, ability, and willingness to manage their own health have better health outcomes. The PAM questionnaire has been tested extensively across a number of different languages, cultures, and demographic groups, and among people with different health conditions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • aged ≥ 65 years old;
  • have at least a 12-month history of T2DM based on the Canadian Diabetes Guidelines;
  • be community-dwelling;
  • live within 30km of their GP clinic in Abbotsford, BC (Canada);
  • able to comply with scheduled visits, treatment plan, and other trial procedures;
  • read, write, and speak English;
  • acceptable auditory acuity to participate in the Group Appointments and visual acuity to participate in the research;
  • provide a personally signed and dated informed consent;
  • able to walk independently;
  • Inclusion will be based on medical history, vital signs, physical examination by study physicians, and written recommendation by family physician, indicating the patient's appropriateness to participate.

Exclusion Criteria:

  • using insulin to treat diabetes to increase the homogeneity of the sample;
  • at high risk for cardiac complications during exercise and/or unable to self-regulate activity or to understand recommended activity level (i.e., Class C of the American Heart Risk Stratification Criteria);
  • Mini-Mental State Examination (MMSE)[51] score of ≤ 24 at screening;
  • have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility;
  • taking medications that may negatively affect the ability to undertake a simple walking program safely (e.g. beta blockers);
  • planning to participate, or already enrolled in, a clinical drug trial concurrent to this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002143


Contacts
Contact: Adriaan Windt, MD 604-859-9084 adriaan.windt@gmail.com
Contact: Jessica Ly, BA, MA 778-998-0851 Jessica.Ly@familymed.ubc.ca

Locations
Canada, British Columbia
Gateway Clinic / Kent Place Clinic Recruiting
Abbotsford, British Columbia, Canada, V2S 3N5
Sub-Investigator: Adriaan Windt, MD         
Centre for Hip Health and Mobility (Vancouver Coastal Health Research Institute/University of British Columbia) Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Principal Investigator: Karim Miran-Khan, MD, PhD, MBA         
Sponsors and Collaborators
University of British Columbia
Ministry of Health, British Columbia
Investigators
Principal Investigator: Karim Miran-Khan, MD, PhD, MBA Centre for Hip Health and Mobility (University of British Columbia)
Study Director: Jennifer Davis, PhD UBC Department of Population & Public Health
Study Director: Martin Dawes, MB.BS, MD UBC Department of Family Practice
Study Director: Christiane Hoppmann, PhD UBC Psychology Department
Study Director: Teresa Liu-Ambrose, PhD, PT UBC Department of Physical Therapy
Study Director: Ken Madden, MD UBC Department of Medicine (Geriatric Medicine)
Study Director: Carlo Marra, Pharm.D, PhD UBC Faculty of Pharmaceutical Sciences
Study Director: Adriaan Windt, MD UBC Department of Family Practice
Study Director: Laura Housden, MN-NP(F) UBC School of Nursing

Publications:
Public Health Agency of Canada. Diabetes in Canada: Facts and figures from a public health perspective 2011. Ottawa: Government of Canada, 2011.
Doucet G, Beatty M. The cost of diabetes in Canada: the economic Tsunami. Can J Diabetes 2010;34:27-29
Noffsinger E. Running Group Visits in Your Practice. NY, New York: Springer, 2009.
Northern Health Authority. The Group Medical Appointment Manual First Edition 2007: Northern Health Authority 2007.
Schwarzer R. Modeling health behavior change: how to predict and modify the adoption and maintenance of health behaviors. Applied Psychology 2008;57(1):1-29
Hologic Inc. Hologic QDR User's Guide. Bedford, MA: Hologic Inc
Canadian Diabetes Association. Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada. Canadian Journal of Diabetes 2013;37(Supplement 1):A1-A16, S1-S216
Slade L, C. H. Time-sampling research in Health Psychology: Potential contributions and new trends. European Health Psychologist 2011;13:65-9
Hoppmann C, Gerstorf D. Spousal goals, affect quality, and collaborative problem solving: Evidence from a time-sampling study with older couples. Research in Human Development 2013;10:70-87
Drummond MF, Sculpher MJ, Torrance GW, et al. Methods for the Economic Evaluation of Health Care Programmes (Third Edition). New York: Oxford University Press 2005.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karim Miran-Khan, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02002143     History of Changes
Other Study ID Numbers: H13-02812
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017

Keywords provided by Karim Miran-Khan, University of British Columbia:
Diabetes
Older People
Seniors
Group Appointments
Group Medical Visits
Shared Appointments
Quality of Life
Physical Activity
Health care Utilization
Depression
Anxiety

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases