Wearable Technology and a Virtual Lifestyle Program for Type 2 Diabetics (STAND-VAT)
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|ClinicalTrials.gov Identifier: NCT04498819|
Recruitment Status : Recruiting
First Posted : August 5, 2020
Last Update Posted : January 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Comorbidities and Coexisting Conditions||Behavioral: Wearable Activity Trackers, Exercise Prescription and Virtual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This study will be a 6-week single cohort prospective feasibility study. The study will involve a total of nine weeks of involvement time, one week of study set-up, one week of baseline, six weeks of intervention time, and in the eighth week a follow-up survey and fitness test. There is one condition; participants are self-selecting themselves to be a part of this intervention being offered, in addition to the usual care offered at the PCDSP clinic.|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Virtually Delivered Lifestyle Program Integrating Wearable Technology and Exercise Prescriptions in Patients With Type 2 Diabetes (STAND-VAT): A Feasibility Study|
|Actual Study Start Date :||November 9, 2020|
|Estimated Primary Completion Date :||May 1, 2021|
|Estimated Study Completion Date :||May 1, 2021|
Experimental: Single Arm
Only one arm, one intervention; this is a feasibility study.
Behavioral: Wearable Activity Trackers, Exercise Prescription and Virtual Care
The intervention is merging wearable activity trackers and tailored aerobic exercise prescriptions into the PCDSP's virtual STAND (a biweekly, evidence based, lifestyle medicine) program.
Participants will wear activity trackers for a week to collect baseline step data (used to create tailored step prescriptions). Biweekly, new step prescriptions will be tailored to each participant based on the previous two week's step count data. The intervention will add onto STAND classes by using activity tracker data into the class discussion for learning opportunities, as well as goal setting and action planning. The day of class, participants will receive a summary email new prescription and encouragement to continue to work hard, using the previous weeks' data to reinforce motivation. The activity tracker will provide instant feedback about step goals, sedentary behaviour and exercise minutes. Individual calls every other week will ensure adherence to exercise regime.
- Feasibility: Recruitment [ Time Frame: from the date of of the first participant recruited the last participant recruited for the study (estimated last date for recruitment cut off is November 14th, 2020; allowing for study data collection completion by December 18, 2020). ]Recruitment levels will be defined as the number of people signed up over number of eligible people approached at intake and in class, presented as a percentage of sign up rates.
- Feasibility: Retention [ Time Frame: From time of consent and up to 9 weeks later (study completion) ]Retention will be calculated as number of participants completed post-intervention follow-up assessment divided by initial sample size.
- Feasibility: Acceptability [ Time Frame: Week 1 of intervention up to time of follow up (7 weeks later) ]Acceptability will be assessed from participant feedback from the exit survey. Acceptability data gathered from the exit survey will be analyzed in a qualitative or descriptive fashion, using frequencies and means (i.e. "this many rated the lottery draw as a motivation to get them to attend class as "strongly agree": 93%"). Technical difficulties will be dealt with (by contact) and recorded by the Master's student in the STAND-VAT activity log. Number of reported technology issues will be reported as a total in addition to average mean # of technology issues per person. Counting will be used based on type of issue using categories like: a) lost/disrupted internet connection or unable to connect or hear or see during class; b) issues utilizing FitBit/FitBit app c) Issues with uploading FitBit data; d) other. Difficulty assessment will provide insight for improvements for larger future studies.
- Feasibility: Adherence [ Time Frame: Week 1 of intervention to week 6 ]Adherence will be assessed by the percent of biweekly classes attended and check-in phone calls answered, as well as number of data submissions (all out of three) as well as monitor adherence: percent of days with FitBit worn (>500 steps) and average percent Libre sensor is active.
- Participant Behaviour; Exercise Behaviours: Daily Step Count [ Time Frame: 1-week Baseline to end of week 6 of intervention (total 7 weeks assessed) ]The change in daily step counts will be measured using repeated, average daily step counts each week collected by the FitBit Inspire HR© during baseline, W1-W6. The mean number of change in daily step counts will be reported.
- Participant Behaviour; Exercise Behaviours: Daily Sedentary Time [ Time Frame: 1-week Baseline to end of week 6 of intervention (total 7 weeks assessed) ]The hourly move goals are used to break and reduce sedentary behaviour. Change in sedentary time will be measured using repeated weekly average daily sedentary minutes collected by the FitBit Inspire HR©, during baseline, W1-W6.
- Participant Behaviour; Exercise Behaviours: Exercise Prescription Adherence [ Time Frame: week 1 to week 6 of intervention ]Adherence to the exercise prescription will be measured by the total number of daily step goals achieved divided by number of days participated throughout the six weeks. The step goals completion numbers demonstrate intervention acceptability and will allow for further reflection on the achievability and appropriate progression rate of the exercise prescriptions. This will be presented as a percentage, calculated by number of days with step goals achieved over total number of days of the program.
- Glycemic Control Measures: Time in Glycemic Target [ Time Frame: Weekly assessment from week 1 to week 6 of intervention ]Weekly average daily time in glycemic target will be repeatedly measured from the first week of the intervention week one (W1) (when the first FreeStyle Libre is applied) and each week until W6.
- Glycemic Control Measures: Estimated A1c [ Time Frame: Weekly assessment from week 1 to week 6 of intervention ]At the clinic, A1c levels are routinely collected every three months. However, since this is a six-week study, A1c will be measured using the weekly average estimated A1c reading from Week 1 (when the first FreeStyle Libre is applied) and each week until week 6.
- Glycemic Control Measures: Percent Coefficient of Variation [ Time Frame: Weekly assessment from week 1 to week 6 of intervention ]Weekly average percent coefficient of variation will be repeatedly measured from the first week of the intervention week one (W1) (when the first FreeStyle Libre is applied) and each week until W6.
- Functional Fitness Levels [ Time Frame: At Baseline and at post-intervention follow-up (7 weeks later) ]Functional fitness levels will be assessed using the two-minute step test. The two minute step test is a two minute, sub maximal test requiring participants to step on the spot, brining knees to mid-thigh level. Scoring is based on number of times the right knee rises within the two minutes.
- Participant Attitudes: Chronic Disease Self-Efficacy [ Time Frame: At Baseline and at post-intervention follow-up (7 weeks later) ]Chronic disease self-efficacy will be measured using the Stanford Self-Efficacy Scale. The Stanford Self-Efficacy Scale is a reliable, validated six-item questionnaire that assesses the self-efficacy to manage a chronic disease, including exercise (Lorig et al., 2001; Ritter & Lorig, 2014). Scores range from 1 (not confident) to 10 (very confident). Higher scores mean higher self-efficacy.
- Participant Attitudes: Diabetes Emotional Distress [ Time Frame: At Baseline and at post-intervention follow-up (7 weeks later) ]Diabetes related emotional distress will be measured using the PAID-5. The five item Problem Areas in Diabetes Scale (PAID-5) is a valid and reliable short version of the PAID Scale, focusing on emotional distress scale (McGuire et al., 2010). Each question is ranked from zero (not a problem) to four (serious problem). A total score of eight or greater indicates possible emotional distress and may warrant further investigation.
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): NCT04498819
|Contact: Sonja Reichert, MD MSc CCFP||519-661-2111 ext 22116||Sonja.Reichert@sjhc.london.on.ca|
|Contact: Elisabeth Harvey, RNEC, MScN||519 646-6000||Elisabeth.Harvey@sjhc.london.on.ca|
|SJHC Primary Care for Diabetes Support Program||Recruiting|
|London, Ontario, Canada, N6G 1J1|
|Contact: Sonja Reichert, MD MSc CCFP 519661-2111 ext 22116 Sonja.Reichert@sjhc.london.on.ca|
|Contact: Elisabeth Harvey, RNEC, MScN 519/646-6000 ext 67268 Elisabeth.Harvey@sjhc.london.on.ca|
|Sub-Investigator: Madison S Hiemstra, BSc|
|Principal Investigator: Sonja Reichert, MD|
|Sub-Investigator: Elisabeth Harvey, RNEC MScN|
|Principal Investigator:||Marc S Mitchell, PhD||Western University|
|Principal Investigator:||Sonja Reichert, MD MSc CCFP||SJHC Primary Care for Diabetes Support Program|