Type 2 Diabetes Mellitus
Conditions
Keywords
Mood Disorders, Self Care, Primary Care
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.
Interventions
BEHAVIORALVEMOFIT
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.
BEHAVIORALAttention-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.
Sponsors
Ministry of Health, Malaysia
UMC Utrecht
Universiti Putra Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes-related distress | 6-week (immediate post-intervention) [T1] | Measured with the 17-item Diabetes Distress Scale (DDS-17) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-care behaviours | 6-week (immediate post-intervention) [T1] | Measured with the Diabetes Self-Care Activities (SDSCA) scale |
| Depression | 6-week (immediate post-intervention) [T1] | Measured with the Patient Health Questionnaire (PHQ-9) |
| Illness perception | 6-week (immediate post-intervention) [T1] | Measured with the Brief Illness Perception Questionnaire (BIPQ) |
| Quality of life | 6-month [T2] | Measured with the WHOQOL-BREF |
| Self-efficacy | 6-week (immediate post-intervention) [T1] | Measured by the Diabetes Management Self Efficacy Scale (DMSES) |
| Blood Pressure | 6-month [T2] | systolic and diastolic blood pressure |
| LDL-cholesterol | 6-week (immediate post-intervention) [T1] | lipid profiles |
| Positive emotions | 6-week (immediate post-intervention) [T1] | Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD) |
| HbA1c | 6-week (immediate post-intervention) [T1] | — |
| Blood pressure | 6-week (immediate post-intervention) [T1] | systolic and diastolic blood pressure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health-care utilisation/hospitalisation | 6-month [T2] | Number of visits to healthcare facilities including hospitalisation, patient's record and diary used in the study |
| Adverse event | 6-week (immediate post-intervention) [T1] | Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary |
Outcome results
None listed