An interventional study of VEMOFIT and Attention-meetings (AG) in Type 2 Diabetes Mellitus, sponsored by Universiti Putra Malaysia. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-12.
Sponsored by Universiti Putra Malaysia · Not applicable, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 124 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Universiti Putra Malaysia is the lead sponsor of 144 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Attention-control
Behavioral: Attention-meetings (AG)
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.
Also known as: Value-based emotion-focused educational programme
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.
Diabetes-related distress
Measured with the 17-item Diabetes Distress Scale (DDS-17)
Time frame: 6-week (immediate post-intervention) [T1]
Diabetes-related distress
Measured with the 17-item Diabetes Distress Scale (DDS-17)
Time frame: 6-month [T2]
Diabetes-related distress
Measured with the 17-item Diabetes Distress Scale (DDS-17)
Time frame: 12-month [T3]
Depression
Measured with the Patient Health Questionnaire (PHQ-9)
Time frame: 6-week (immediate post-intervention) [T1]
Depression
Measured with the Patient Health Questionnaire (PHQ-9)
Time frame: 6-month [T2]
Depression
Measured with the Patient Health Questionnaire (PHQ-9)
Time frame: 12-month [T3]
Illness perception
Measured with the Brief Illness Perception Questionnaire (BIPQ)
Time frame: 6-week (immediate post-intervention) [T1]
Illness perception
Measured with the Brief Illness Perception Questionnaire (BIPQ)
Time frame: 6-month [T2]
Illness perception
Measured with the Brief Illness Perception Questionnaire (BIPQ)
Time frame: 12-month [T3]
Quality of life
Measured with the WHOQOL-BREF
Time frame: 6-month [T2]
Quality of life
Measured with the WHOQOL-BREF
Time frame: 12-month [T3]
Self-efficacy
Measured by the Diabetes Management Self Efficacy Scale (DMSES)
Time frame: 6-week (immediate post-intervention) [T1]
Self-efficacy
Measured by the Diabetes Management Self Efficacy Scale (DMSES)
Time frame: 6-month [T2]
Self-efficacy
Measured by the Diabetes Management Self Efficacy Scale (DMSES)
Time frame: 12-month [T3]
Self-care behaviours
Measured with the Diabetes Self-Care Activities (SDSCA) scale
Time frame: 6-week (immediate post-intervention) [T1]
Self-care behaviours
Measured with the Diabetes Self-Care Activities (SDSCA) scale
Time frame: 6-month [T2]
Self-care behaviours
Measured with the Diabetes Self-Care Activities (SDSCA) scale
Time frame: 12-month [T3]
Positive emotions
Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD)
Time frame: 6-week (immediate post-intervention) [T1]
Positive emotions
Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD)
Time frame: 6-month [T2]
Positive emotions
Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD)
Time frame: 12-month [T3]
HbA1c
Time frame: 6-week (immediate post-intervention) [T1]
HbA1c
Time frame: 6-month [T2]
HbA1c
Time frame: 12-month [T3]
Blood pressure
systolic and diastolic blood pressure
Time frame: 6-week (immediate post-intervention) [T1]
Blood Pressure
systolic and diastolic blood pressure
Time frame: 6-month [T2]
Blood pressure
systolic and diastolic blood pressure
Time frame: 12-month [T3]
LDL-cholesterol
lipid profiles
Time frame: 6-week (immediate post-intervention) [T1]
LDL-cholesterol
lipid profiles
Time frame: 6-month [T2]
LDL-cholesterol
lipid profiles
Time frame: 12-month [T3]
Health-care utilisation/hospitalisation
Number of visits to healthcare facilities including hospitalisation, patient's record and diary used in the study
Time frame: 6-month [T2]
Health-care utilisation/hospitalisation
Number of visits to healthcare facilities including hospitalisation, patient's record and diary used in the study
Time frame: 12-month [T3]
Adverse event
Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary
Time frame: 6-week (immediate post-intervention) [T1]
Adverse event
Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary
Time frame: 6-month [T2]
Adverse event
Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary
Time frame: 12-month [T3]
No study locations are listed for this record.
Plan to share: Yes — Anonymous data will be accessible publicly via the figshare.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Universiti Putra Malaysia