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Value-based Emotion-focused Educational Programme to Reduce Diabetes-related Distress (VEMOFIT)

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ClinicalTrials.gov Identifier: NCT02730078
Recruitment Status : Enrolling by invitation
First Posted : April 6, 2016
Last Update Posted : October 25, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of the clinical trial is to evaluate the effectiveness of a relatively simple and short value-based emotion-focused educational programme in adults with type 2 diabetes (VEMOFIT) on diabetes-related distress, depressive symptoms, illness perception, medication adherence, quality of life, diabetes self-efficacy, self-care and clinical outcomes.

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Behavioral: VEMOFIT Behavioral: Attention-meetings (AG)

Detailed Description:
Type 2 diabetes (T2D) patients experience many psychosocial problems related to their diabetes, as well as social- and work-related relationships. These often lead to emotional disorders such as distress, stress, anxiety and depression. Without proper care, these patients use more often negative coping strategies and more frequently expect that their diabetes will negatively affect their future. A cluster randomised controlled trial will be conducted in 10 public health clinics (HC) in Malaysia. These clusters are eligible if they are providing standard diabetes care according to national clinical practice guidelines, not involved in similar trial and having nurses to be trained to deliver the VEMOFIT educational programmes. Pre-stratification by cluster size and geographic areas of the HCs will get randomised five HCs to the VEMOFIT group (VG) and attention-meetings group (AG), respectively.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness of a Value-based Emotion-focused Educational Programme to Reduce Diabetes-related Distress in Malay Adults With Type 2 Diabetes (VEMOFIT): a Cluster Randomised Controlled Trial
Study Start Date : April 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Attention-meetings (AG)
Attention-control
Behavioral: Attention-meetings (AG)
Patients in the health clinics randomised to the AG, will receive the usual T2D care by the clinic doctors and education by the clinic paramedics based on the recommendations in the Malaysian clinical guidelines. At T1, T2 and T4, patients (not including their significant others) in AG will be gathered in groups of 10-12 people for the primary and secondary outcomes evaluation. This session will include general discussion on feeling about and coping with T2D, social support at home and satisfaction with treatment and care received at the respective clinics.
Experimental: VEMOFIT (VG)
Personal value exploration, disease education, emotional skills and goal setting.
Behavioral: VEMOFIT
The VEMOFIT intervention involves four biweekly two hours sessions over a period of about six weeks, and a booster at three months follow-up. It consists of a mixture of 1) exploring illness perceptions and personal meanings of diabetes, 2) cognition-focused education on diabetes and practical skills in self-management and 3) emotion-focused training on recognising emotions in the self and others. Each group will consist of 10 to 12 participants of equal representation by the patients and their significant others.
Other Name: Value-based emotion-focused educational programme


Outcome Measures

Primary Outcome Measures :
  1. Diabetes-related distress [ Time Frame: 6-week (immediate post-intervention) [T1] ]
    Measured with the 17-item Diabetes Distress Scale (DDS-17)

  2. Diabetes-related distress [ Time Frame: 6-month [T2] ]
    Measured with the 17-item Diabetes Distress Scale (DDS-17)

  3. Diabetes-related distress [ Time Frame: 12-month [T3] ]
    Measured with the 17-item Diabetes Distress Scale (DDS-17)


Secondary Outcome Measures :
  1. Depression [ Time Frame: 6-week (immediate post-intervention) [T1] ]
    Measured with the Patient Health Questionnaire (PHQ-9)

  2. Depression [ Time Frame: 6-month [T2] ]
    Measured with the Patient Health Questionnaire (PHQ-9)

  3. Depression [ Time Frame: 12-month [T3] ]
    Measured with the Patient Health Questionnaire (PHQ-9)

  4. Illness perception [ Time Frame: 6-week (immediate post-intervention) [T1] ]
    Measured with the Brief Illness Perception Questionnaire (BIPQ)

  5. Illness perception [ Time Frame: 6-month [T2] ]
    Measured with the Brief Illness Perception Questionnaire (BIPQ)

  6. Illness perception [ Time Frame: 12-month [T3] ]
    Measured with the Brief Illness Perception Questionnaire (BIPQ)

  7. Quality of life [ Time Frame: 6-month [T2] ]
    Measured with the WHOQOL-BREF

  8. Quality of life [ Time Frame: 12-month [T3] ]
    Measured with the WHOQOL-BREF

  9. Self-efficacy [ Time Frame: 6-week (immediate post-intervention) [T1] ]
    Measured by the Diabetes Management Self Efficacy Scale (DMSES)

  10. Self-efficacy [ Time Frame: 6-month [T2] ]
    Measured by the Diabetes Management Self Efficacy Scale (DMSES)

  11. Self-efficacy [ Time Frame: 12-month [T3] ]
    Measured by the Diabetes Management Self Efficacy Scale (DMSES)

  12. Self-care behaviours [ Time Frame: 6-week (immediate post-intervention) [T1] ]
    Measured with the Diabetes Self-Care Activities (SDSCA) scale

  13. Self-care behaviours [ Time Frame: 6-month [T2] ]
    Measured with the Diabetes Self-Care Activities (SDSCA) scale

  14. Self-care behaviours [ Time Frame: 12-month [T3] ]
    Measured with the Diabetes Self-Care Activities (SDSCA) scale

  15. Positive emotions [ Time Frame: 6-week (immediate post-intervention) [T1] ]
    Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD)

  16. Positive emotions [ Time Frame: 6-month [T2] ]
    Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD)

  17. Positive emotions [ Time Frame: 12-month [T3] ]
    Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD)

  18. HbA1c [ Time Frame: 6-week (immediate post-intervention) [T1] ]
  19. HbA1c [ Time Frame: 6-month [T2] ]
  20. HbA1c [ Time Frame: 12-month [T3] ]
  21. Blood pressure [ Time Frame: 6-week (immediate post-intervention) [T1] ]
    systolic and diastolic blood pressure

  22. Blood Pressure [ Time Frame: 6-month [T2] ]
    systolic and diastolic blood pressure

  23. Blood pressure [ Time Frame: 12-month [T3] ]
    systolic and diastolic blood pressure

  24. LDL-cholesterol [ Time Frame: 6-week (immediate post-intervention) [T1] ]
    lipid profiles

  25. LDL-cholesterol [ Time Frame: 6-month [T2] ]
    lipid profiles

  26. LDL-cholesterol [ Time Frame: 12-month [T3] ]
    lipid profiles


Other Outcome Measures:
  1. Health-care utilisation/hospitalisation [ Time Frame: 6-month [T2] ]
    Number of visits to healthcare facilities including hospitalisation, patient's record and diary used in the study

  2. Health-care utilisation/hospitalisation [ Time Frame: 12-month [T3] ]
    Number of visits to healthcare facilities including hospitalisation, patient's record and diary used in the study

  3. Adverse event [ Time Frame: 6-week (immediate post-intervention) [T1] ]
    Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary

  4. Adverse event [ Time Frame: 6-month [T2] ]
    Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary

  5. Adverse event [ Time Frame: 12-month [T3] ]
    Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Malay patients
  • Diagnosed with T2D for at least two years
  • On regular follow-up with at least three visits in the past one year
  • Have diabetes-related distress (mean DDS-17 score ≥ 3)
  • Showing poor disease control (not reaching targets for one of the three biomarkers, namely HbA1c ≥ 8%, blood pressure ≥ 140/90 mmHg and LDL-C > 2.6 mmol/L)

Exclusion Criteria:

  • Patients who are enrolled in other clinical studies
  • Pregnant or lactating
  • Having psychiatric/ psychological disorders that could impair judgments and memory
  • Patients who cannot read or understand English or Malay
  • Patients who scored ≥ 20 on the Patient Health Questionnaire-9 (PHQ-9) that suggest a severe depression
Contacts and Locations

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): NCT02730078


Sponsors and Collaborators
Universiti Putra Malaysia
Ministry of Health, Malaysia
UMC Utrecht
Investigators
Principal Investigator: Boon-How Chew, MMed Universiti Putra Malaysia
More Information

Additional Information:
Publications:
Responsible Party: Boon-How Chew, Associate Professor, Universiti Putra Malaysia
ClinicalTrials.gov Identifier: NCT02730078     History of Changes
Other Study ID Numbers: NMRR- 15-1144-24803
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymous data will be accessible publicly via the figshare.

Keywords provided by Boon-How Chew, Universiti Putra Malaysia:
Mood Disorders
Self Care
Primary Care

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