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

Type 2 Diabetes Mellitus Clinical Trial

— VEMOFIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730078
• Other study ID #: NMRR- 15-1144-24803
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2017

Study information

• Verified date: July 2019
• Source: Universiti Putra Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Universiti Putra Malaysia	Ministry of Health, Malaysia, UMC Utrecht

References & Publications (7)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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 ran — View Citation

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:CD011469. doi: 10.1002/14651858.CD011469.pub2. Review. — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health-care utilisation/hospitalisation	Number of visits to healthcare facilities including hospitalisation, patient's record and diary used in the study	6-month [T2]
Other	Health-care utilisation/hospitalisation	Number of visits to healthcare facilities including hospitalisation, patient's record and diary used in the study	12-month [T3]
Other	Adverse event	Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary	6-week (immediate post-intervention) [T1]
Other	Adverse event	Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary	6-month [T2]
Other	Adverse event	Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary	12-month [T3]
Primary	Diabetes-related distress	Measured with the 17-item Diabetes Distress Scale (DDS-17)	6-week (immediate post-intervention) [T1]
Primary	Diabetes-related distress	Measured with the 17-item Diabetes Distress Scale (DDS-17)	6-month [T2]
Primary	Diabetes-related distress	Measured with the 17-item Diabetes Distress Scale (DDS-17)	12-month [T3]
Secondary	Depression	Measured with the Patient Health Questionnaire (PHQ-9)	6-week (immediate post-intervention) [T1]
Secondary	Depression	Measured with the Patient Health Questionnaire (PHQ-9)	6-month [T2]
Secondary	Depression	Measured with the Patient Health Questionnaire (PHQ-9)	12-month [T3]
Secondary	Illness perception	Measured with the Brief Illness Perception Questionnaire (BIPQ)	6-week (immediate post-intervention) [T1]
Secondary	Illness perception	Measured with the Brief Illness Perception Questionnaire (BIPQ)	6-month [T2]
Secondary	Illness perception	Measured with the Brief Illness Perception Questionnaire (BIPQ)	12-month [T3]
Secondary	Quality of life	Measured with the WHOQOL-BREF	6-month [T2]
Secondary	Quality of life	Measured with the WHOQOL-BREF	12-month [T3]
Secondary	Self-efficacy	Measured by the Diabetes Management Self Efficacy Scale (DMSES)	6-week (immediate post-intervention) [T1]
Secondary	Self-efficacy	Measured by the Diabetes Management Self Efficacy Scale (DMSES)	6-month [T2]
Secondary	Self-efficacy	Measured by the Diabetes Management Self Efficacy Scale (DMSES)	12-month [T3]
Secondary	Self-care behaviours	Measured with the Diabetes Self-Care Activities (SDSCA) scale	6-week (immediate post-intervention) [T1]
Secondary	Self-care behaviours	Measured with the Diabetes Self-Care Activities (SDSCA) scale	6-month [T2]
Secondary	Self-care behaviours	Measured with the Diabetes Self-Care Activities (SDSCA) scale	12-month [T3]
Secondary	Positive emotions	Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD)	6-week (immediate post-intervention) [T1]
Secondary	Positive emotions	Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD)	6-month [T2]
Secondary	Positive emotions	Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD)	12-month [T3]
Secondary	HbA1c		6-week (immediate post-intervention) [T1]
Secondary	HbA1c		6-month [T2]
Secondary	HbA1c		12-month [T3]
Secondary	Blood pressure	systolic and diastolic blood pressure	6-week (immediate post-intervention) [T1]
Secondary	Blood Pressure	systolic and diastolic blood pressure	6-month [T2]
Secondary	Blood pressure	systolic and diastolic blood pressure	12-month [T3]
Secondary	LDL-cholesterol	lipid profiles	6-week (immediate post-intervention) [T1]
Secondary	LDL-cholesterol	lipid profiles	6-month [T2]
Secondary	LDL-cholesterol	lipid profiles	12-month [T3]

External Links

•   Study protocol published in Springer BMC Endocrine Disorders