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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02730078
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : July 12, 2019
Sponsor:
Collaborators:
Ministry of Health, Malaysia
UMC Utrecht
Information provided by (Responsible Party):
Boon-How Chew, Universiti Putra Malaysia

Tracking Information
First Submitted Date  ICMJE March 29, 2016
First Posted Date  ICMJE April 6, 2016
Last Update Posted Date July 12, 2019
Actual Study Start Date  ICMJE April 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2016)
  • Diabetes-related distress [ Time Frame: 6-week (immediate post-intervention) [T1] ]
    Measured with the 17-item Diabetes Distress Scale (DDS-17)
  • Diabetes-related distress [ Time Frame: 6-month [T2] ]
    Measured with the 17-item Diabetes Distress Scale (DDS-17)
  • Diabetes-related distress [ Time Frame: 12-month [T3] ]
    Measured with the 17-item Diabetes Distress Scale (DDS-17)
Original Primary Outcome Measures  ICMJE
 (submitted: March 31, 2016)
  • Diabetes-related distress [ Time Frame: 6-week (immediate post-intervention) [T2] ]
    Measured with the 17-item Diabetes Distress Scale (DDS-17)
  • Diabetes-related distress [ Time Frame: 6-month [T4] ]
    Measured with the 17-item Diabetes Distress Scale (DDS-17)
  • Diabetes-related distress [ Time Frame: 12-month [T5] ]
    Measured with the 17-item Diabetes Distress Scale (DDS-17)
  • Diabetes-related distress [ Time Frame: 24-month [T6] ]
    Measured with the 17-item Diabetes Distress Scale (DDS-17)
Change History Complete list of historical versions of study NCT02730078 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2017)
  • Depression [ Time Frame: 6-week (immediate post-intervention) [T1] ]
    Measured with the Patient Health Questionnaire (PHQ-9)
  • Depression [ Time Frame: 6-month [T2] ]
    Measured with the Patient Health Questionnaire (PHQ-9)
  • Depression [ Time Frame: 12-month [T3] ]
    Measured with the Patient Health Questionnaire (PHQ-9)
  • Illness perception [ Time Frame: 6-week (immediate post-intervention) [T1] ]
    Measured with the Brief Illness Perception Questionnaire (BIPQ)
  • Illness perception [ Time Frame: 6-month [T2] ]
    Measured with the Brief Illness Perception Questionnaire (BIPQ)
  • Illness perception [ Time Frame: 12-month [T3] ]
    Measured with the Brief Illness Perception Questionnaire (BIPQ)
  • Quality of life [ Time Frame: 6-month [T2] ]
    Measured with the WHOQOL-BREF
  • Quality of life [ Time Frame: 12-month [T3] ]
    Measured with the WHOQOL-BREF
  • Self-efficacy [ Time Frame: 6-week (immediate post-intervention) [T1] ]
    Measured by the Diabetes Management Self Efficacy Scale (DMSES)
  • Self-efficacy [ Time Frame: 6-month [T2] ]
    Measured by the Diabetes Management Self Efficacy Scale (DMSES)
  • Self-efficacy [ Time Frame: 12-month [T3] ]
    Measured by the Diabetes Management Self Efficacy Scale (DMSES)
  • Self-care behaviours [ Time Frame: 6-week (immediate post-intervention) [T1] ]
    Measured with the Diabetes Self-Care Activities (SDSCA) scale
  • Self-care behaviours [ Time Frame: 6-month [T2] ]
    Measured with the Diabetes Self-Care Activities (SDSCA) scale
  • Self-care behaviours [ Time Frame: 12-month [T3] ]
    Measured with the Diabetes Self-Care Activities (SDSCA) scale
  • 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)
  • Positive emotions [ Time Frame: 6-month [T2] ]
    Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD)
  • Positive emotions [ Time Frame: 12-month [T3] ]
    Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD)
  • HbA1c [ Time Frame: 6-week (immediate post-intervention) [T1] ]
  • HbA1c [ Time Frame: 6-month [T2] ]
  • HbA1c [ Time Frame: 12-month [T3] ]
  • Blood pressure [ Time Frame: 6-week (immediate post-intervention) [T1] ]
    systolic and diastolic blood pressure
  • Blood Pressure [ Time Frame: 6-month [T2] ]
    systolic and diastolic blood pressure
  • Blood pressure [ Time Frame: 12-month [T3] ]
    systolic and diastolic blood pressure
  • LDL-cholesterol [ Time Frame: 6-week (immediate post-intervention) [T1] ]
    lipid profiles
  • LDL-cholesterol [ Time Frame: 6-month [T2] ]
    lipid profiles
  • LDL-cholesterol [ Time Frame: 12-month [T3] ]
    lipid profiles
Original Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2016)
  • Depression [ Time Frame: 6-week (immediate post-intervention) [T2] ]
    Measured with the Patient Health Questionnaire (PHQ-9)
  • Depression [ Time Frame: 6-month [T4] ]
    Measured with the Patient Health Questionnaire (PHQ-9)
  • Depression [ Time Frame: 12-month [T5] ]
    Measured with the Patient Health Questionnaire (PHQ-9)
  • Depression [ Time Frame: 24-month [T6] ]
    Measured with the Patient Health Questionnaire (PHQ-9)
  • Illness perception [ Time Frame: 6-week (immediate post-intervention) [T2] ]
    Measured with the Brief Illness Perception Questionnaire (BIPQ)
  • Illness perception [ Time Frame: 6-month [T4] ]
    Measured with the Brief Illness Perception Questionnaire (BIPQ)
  • Illness perception [ Time Frame: 12-month [T5] ]
    Measured with the Brief Illness Perception Questionnaire (BIPQ)
  • Illness perception [ Time Frame: 24-month [T6] ]
    Measured with the Brief Illness Perception Questionnaire (BIPQ)
  • Quality of life [ Time Frame: 6-month [T4] ]
    Measured with the WHOQOL-BREF
  • Quality of life [ Time Frame: 12-month [T5] ]
    Measured with the WHOQOL-BREF
  • Quality of life [ Time Frame: 24-month [T6] ]
    Measured with the WHOQOL-BREF
  • Self-efficacy [ Time Frame: 6-week (immediate post-intervention) [T2] ]
    Measured by the Diabetes Management Self Efficacy Scale (DMSES)
  • Self-efficacy [ Time Frame: 6-month [T4] ]
    Measured by the Diabetes Management Self Efficacy Scale (DMSES)
  • Self-efficacy [ Time Frame: 12-month [T5] ]
    Measured by the Diabetes Management Self Efficacy Scale (DMSES)
  • Self-efficacy [ Time Frame: 24-month [T6] ]
    Measured by the Diabetes Management Self Efficacy Scale (DMSES)
  • Self-care behaviours [ Time Frame: 6-week (immediate post-intervention) [T2] ]
    Measured with the Diabetes Self-Care Activities (SDSCA) scale
  • Self-care behaviours [ Time Frame: 6-month [T4] ]
    Measured with the Diabetes Self-Care Activities (SDSCA) scale
  • Self-care behaviours [ Time Frame: 12-month [T5] ]
    Measured with the Diabetes Self-Care Activities (SDSCA) scale
  • Self-care behaviours [ Time Frame: 24-month [T6] ]
    Measured with the Diabetes Self-Care Activities (SDSCA) scale
  • Treatment adherence [ Time Frame: 6-week (immediate post-intervention) [T2] ]
    Measured with the eight-item Morisky Medication Adherence (MMAS-8) Scale
  • Treatment adherence [ Time Frame: 6-month [T4] ]
    Measured with the eight-item Morisky Medication Adherence (MMAS-8) Scale
  • Treatment adherence [ Time Frame: 12-month [T5] ]
    Measured with the eight-item Morisky Medication Adherence (MMAS-8) Scale
  • Treatment adherence [ Time Frame: 24-month [T6] ]
    Measured with the eight-item Morisky Medication Adherence (MMAS-8) Scale
  • Positive emotions [ Time Frame: 6-week (immediate post-intervention) [T2] ]
    Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD)
  • Positive emotions [ Time Frame: 6-month [T4] ]
    Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD)
  • Positive emotions [ Time Frame: 12-month [T5] ]
    Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD)
  • Positive emotions [ Time Frame: 24-month [T6] ]
    Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD)
  • HbA1c [ Time Frame: 6-week (immediate post-intervention) [T2] ]
  • HbA1c [ Time Frame: 6-month [T4] ]
  • HbA1c [ Time Frame: 12-month [T5] ]
  • HbA1c [ Time Frame: 24-month [T6] ]
  • Blood pressure [ Time Frame: 6-week (immediate post-intervention) [T2] ]
    systolic and diastolic blood pressure
  • Blood Pressure [ Time Frame: 6-month [T4] ]
    systolic and diastolic blood pressure
  • Blood pressure [ Time Frame: 12-month [T5] ]
    systolic and diastolic blood pressure
  • Blood pressure [ Time Frame: 24-month [T6] ]
    systolic and diastolic blood pressure
  • LDL-cholesterol [ Time Frame: 6-week (immediate post-intervention) [T2] ]
    lipid profiles
  • LDL-cholesterol [ Time Frame: 6-month [T4] ]
    lipid profiles
  • LDL-cholesterol [ Time Frame: 12-month [T5] ]
    lipid profiles
  • LDL-cholesterol [ Time Frame: 24-month [T6] ]
    lipid profiles
  • Participant programme evaluation [ Time Frame: 3-month [T3] ]
    12-item 5-point Likert-type (strongly agree to strongly disagree)
Current Other Pre-specified Outcome Measures
 (submitted: April 26, 2016)
  • 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
  • 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
  • Adverse event [ Time Frame: 6-week (immediate post-intervention) [T1] ]
    Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary
  • Adverse event [ Time Frame: 6-month [T2] ]
    Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary
  • Adverse event [ Time Frame: 12-month [T3] ]
    Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary
Original Other Pre-specified Outcome Measures
 (submitted: March 31, 2016)
  • Health-care utilisation/hospitalisation [ Time Frame: 6-month [T4] ]
    Number of visits to healthcare facilities including hospitalisation, patient's record and diary used in the study
  • Health-care utilisation/hospitalisation [ Time Frame: 12-month [T5] ]
    Number of visits to healthcare facilities including hospitalisation, patient's record and diary used in the study
  • Health-care utilisation/hospitalisation [ Time Frame: 24-month [T6] ]
    Number of visits to healthcare facilities including hospitalisation, from patient's record and diary used in the study
  • Adverse event [ Time Frame: 6-week (immediate post-intervention) [T2] ]
    Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary
  • Adverse event [ Time Frame: 6-month [T4] ]
    Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary
  • Adverse event [ Time Frame: 12-month [T5] ]
    Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary
  • Adverse event [ Time Frame: 24-month [T6] ]
    Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary
 
Descriptive Information
Brief Title  ICMJE Value-based Emotion-focused Educational Programme to Reduce Diabetes-related Distress
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Active Comparator: Attention-meetings (AG)
    Attention-control
    Intervention: Behavioral: Attention-meetings (AG)
  • Experimental: VEMOFIT (VG)
    Personal value exploration, disease education, emotional skills and goal setting.
    Intervention: Behavioral: VEMOFIT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2018)
124
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2016)
200
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02730078
Other Study ID Numbers  ICMJE NMRR- 15-1144-24803
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymous data will be accessible publicly via the figshare.
Responsible Party Boon-How Chew, Universiti Putra Malaysia
Study Sponsor  ICMJE Universiti Putra Malaysia
Collaborators  ICMJE
  • Ministry of Health, Malaysia
  • UMC Utrecht
Investigators  ICMJE
Principal Investigator: Boon-How Chew, MMed Universiti Putra Malaysia
PRS Account Universiti Putra Malaysia
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP