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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Emotional Disorders and Outcomes in Adults With Type 2 Diabetes Mellitus at Primary Care

NCT02730754

Type 2 Diabetes Mellitus

COMPLETED

Mindfulness-Based Diabetes Education for Adults With Elevated Diabetes Distress

NCT05195138

Type 2 Diabetes

RECRUITING NA

Remotely Delivered Mindfulness-Based Diabetes Education

NCT06312553

Type 2 Diabetes

NOT_YET_RECRUITING NA

Intervention Mapping to Adapt a Mindfulness-based Intervention for Adults With Diabetes and Emotional Distress

NCT03987841

Type 2 Diabetes Stress

COMPLETED NA

Development of Diabetes Mobile Application

NCT04686201

Type 2 Diabetes Mellitus

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Attention-meetings (AG)

Attention-control

Group Type ACTIVE_COMPARATOR

Attention-meetings (AG)

Intervention Type 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.

VEMOFIT (VG)

Personal value exploration, disease education, emotional skills and goal setting.

Group Type EXPERIMENTAL

VEMOFIT

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Value-based emotion-focused educational programme

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No