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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Behavioral: Attention-meetings (AG); Behavioral: VEMOFIT

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: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Attention-meetings (AG); Attention-control	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.
Experimental: VEMOFIT (VG); 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.; Other Names: Value-based emotion-focused educational programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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]

Secondary Outcome Measures

Outcome Measure	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)	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]

Other Outcome Measures

Outcome Measure	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	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]

Collaborators and Investigators

• Sponsor: Universiti Putra Malaysia
• Collaborators: UMC Utrecht; Ministry of Health, Malaysia
• Investigators: Principal Investigator: Boon-How Chew, MMed, Universiti Putra Malaysia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Study protocol published in Springer BMC Endocrine Disorders

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: March 29, 2016
• First Submitted That Met QC Criteria: March 31, 2016
• First Posted (Estimate): April 6, 2016

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Primary Care; Mood Disorders; Self Care
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NMRR- 15-1144-24803

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymous data will be accessible publicly via the figshare.