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| Name | Class |
|---|---|
| Ministry of Health, Malaysia | OTHER_GOV |
| UMC Utrecht | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attention-meetings (AG) | Active Comparator | Attention-control |
|
| VEMOFIT (VG) | Experimental | Personal value exploration, disease education, emotional skills and goal setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes-related distress | Measured with the 17-item Diabetes Distress Scale (DDS-17) | 6-week (immediate post-intervention) [T1] |
| Diabetes-related distress | Measured with the 17-item Diabetes Distress Scale (DDS-17) | 6-month [T2] |
| Diabetes-related distress | Measured with the 17-item Diabetes Distress Scale (DDS-17) | 12-month [T3] |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | Measured with the Patient Health Questionnaire (PHQ-9) | 6-week (immediate post-intervention) [T1] |
| Depression | Measured with the Patient Health Questionnaire (PHQ-9) |
| Measure | Description | Time Frame |
|---|---|---|
| Health-care utilisation/hospitalisation | Number of visits to healthcare facilities including hospitalisation, patient's record and diary used in the study | 6-month [T2] |
| Health-care utilisation/hospitalisation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boon-How Chew, MMed | Universiti Putra Malaysia | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28376921 | Background | Chew BH, Vos RC, Shariff Ghazali S, Shamsuddin NH, Fernandez A, Mukhtar F, Ismail M, Mohd Ahad A, Sundram NN, Ali SZ, Rutten GE. The effectiveness of a value-based EMOtion-cognition-Focused educatIonal programme to reduce diabetes-related distress in Malay adults with Type 2 diabetes (VEMOFIT): study protocol for a cluster randomised controlled trial. BMC Endocr Disord. 2017 Apr 4;17(1):22. doi: 10.1186/s12902-017-0172-8. | |
| 28954185 |
| Label | URL |
|---|---|
| Study protocol published in Springer BMC Endocrine Disorders | View source |
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Anonymous data will be accessible publicly via the figshare.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. |
|
| 6-month [T2] |
| Depression | Measured with the Patient Health Questionnaire (PHQ-9) | 12-month [T3] |
| Illness perception | Measured with the Brief Illness Perception Questionnaire (BIPQ) | 6-week (immediate post-intervention) [T1] |
| Illness perception | Measured with the Brief Illness Perception Questionnaire (BIPQ) | 6-month [T2] |
| Illness perception | Measured with the Brief Illness Perception Questionnaire (BIPQ) | 12-month [T3] |
| Quality of life | Measured with the WHOQOL-BREF | 6-month [T2] |
| Quality of life | Measured with the WHOQOL-BREF | 12-month [T3] |
| Self-efficacy | Measured by the Diabetes Management Self Efficacy Scale (DMSES) | 6-week (immediate post-intervention) [T1] |
| Self-efficacy | Measured by the Diabetes Management Self Efficacy Scale (DMSES) | 6-month [T2] |
| Self-efficacy | Measured by the Diabetes Management Self Efficacy Scale (DMSES) | 12-month [T3] |
| Self-care behaviours | Measured with the Diabetes Self-Care Activities (SDSCA) scale | 6-week (immediate post-intervention) [T1] |
| Self-care behaviours | Measured with the Diabetes Self-Care Activities (SDSCA) scale | 6-month [T2] |
| Self-care behaviours | Measured with the Diabetes Self-Care Activities (SDSCA) scale | 12-month [T3] |
| Positive emotions | Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD) | 6-week (immediate post-intervention) [T1] |
| Positive emotions | Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD) | 6-month [T2] |
| Positive emotions | Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD) | 12-month [T3] |
| HbA1c | 6-week (immediate post-intervention) [T1] |
| HbA1c | 6-month [T2] |
| HbA1c | 12-month [T3] |
| Blood pressure | systolic and diastolic blood pressure | 6-week (immediate post-intervention) [T1] |
| Blood Pressure | systolic and diastolic blood pressure | 6-month [T2] |
| Blood pressure | systolic and diastolic blood pressure | 12-month [T3] |
| LDL-cholesterol | lipid profiles | 6-week (immediate post-intervention) [T1] |
| LDL-cholesterol | lipid profiles | 6-month [T2] |
| LDL-cholesterol | lipid profiles | 12-month [T3] |
Number of visits to healthcare facilities including hospitalisation, patient's record and diary used in the study
| 12-month [T3] |
| Adverse event | Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary | 6-week (immediate post-intervention) [T1] |
| Adverse event | Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary | 6-month [T2] |
| Adverse event | Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary | 12-month [T3] |
| Background |
| Chew BH, Vos RC, Metzendorf MI, Scholten RJ, Rutten GE. Psychological interventions for diabetes-related distress in adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2017 Sep 27;9(9):CD011469. doi: 10.1002/14651858.CD011469.pub2. |
| 29765258 | Background | Chew BH, Fernandez A, Shariff-Ghazali S. Psychological interventions for behavioral adjustments in diabetes care - a value-based approach to disease control. Psychol Res Behav Manag. 2018 May 4;11:145-155. doi: 10.2147/PRBM.S117224. eCollection 2018. |
| 25512782 | Background | Chew BH, Shariff-Ghazali S, Fernandez A. Psychological aspects of diabetes care: Effecting behavioral change in patients. World J Diabetes. 2014 Dec 15;5(6):796-808. doi: 10.4239/wjd.v5.i6.796. |
| 27099658 | Background | Chew BH, Mukhtar F, Sherina MS, Paimin F, Hassan NH, Jamaludin NK. The reliability and validity of the Malay version 17-item Diabetes Distress Scale. Malays Fam Physician. 2015 Aug 31;10(2):22-35. eCollection 2015. |
| 29505098 | Result | Chew BH, Vos RC, Stellato RK, Ismail M, Rutten GEHM. The effectiveness of an emotion-focused educational programme in reducing diabetes distress in adults with Type 2 diabetes mellitus (VEMOFIT): a cluster randomized controlled trial. Diabet Med. 2018 Jun;35(6):750-759. doi: 10.1111/dme.13615. Epub 2018 Mar 30. |
| 31210922 | Result | Chew BH, Vos RC, Fernandez A, Shariff Ghazali S, Shamsuddin NH, Ismail M, Rutten GEHM. The effectiveness of an emotion-focused educational programme in reducing diabetes distress in adults with type 2 diabetes mellitus at 12-month follow-up: a cluster randomized controlled trial. Ther Adv Endocrinol Metab. 2019 May 31;10:2042018819853761. doi: 10.1177/2042018819853761. eCollection 2019. |
| 28774271 | Derived | Chew BH, Vos RC, Heijmans M, Shariff-Ghazali S, Fernandez A, Rutten GEHM. Validity and reliability of a Malay version of the brief illness perception questionnaire for patients with type 2 diabetes mellitus. BMC Med Res Methodol. 2017 Aug 3;17(1):118. doi: 10.1186/s12874-017-0394-5. |
| D004700 | Endocrine System Diseases |
| D001523 | Mental Disorders |