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Completed

NCT Number: NCT02730078

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Mood Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VEMOFIT

Behavioral

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 names: Value-based emotion-focused educational programme

Attention-meetings (AG)

Behavioral

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Collaborators

  • Ministry of Health, Malaysia
  • UMC Utrecht

Registry information

Official study 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

Acronym: VEMOFIT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 6, 2016
Registry last updated
Jul 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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