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

NCT02730078 | Completed DMC

• 1 other identifier: NMRR- 15-1144-24803
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Mood Disorders; Self Care; Primary Care

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (26)

• Depression

  6-week (immediate post-intervention) [T1]

• Depression

  6-month [T2]

• Depression

  12-month [T3]

• Illness perception

  6-week (immediate post-intervention) [T1]

• Illness perception

  6-month [T2]

Other Outcomes (5)

• Health-care utilisation/hospitalisation

  6-month [T2]

• Health-care utilisation/hospitalisation

  12-month [T3]

• Adverse event

  6-week (immediate post-intervention) [T1]

Study Arms (2)

Attention-meetings (AG)

ACTIVE COMPARATOR

Attention-control

Behavioral: Attention-meetings (AG)

VEMOFIT (VG)

EXPERIMENTAL

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

Behavioral: VEMOFIT

Interventions

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.

Also known as: Value-based emotion-focused educational programme

VEMOFIT (VG)

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.

Attention-meetings (AG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• Ministry of Health, Malaysia: collaborator
• UMC Utrecht: collaborator

Related Publications (8)

• 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.

  PMID: 28376921 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.

  PMID: 28954185 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.

  PMID: 29765258 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.

  PMID: 25512782 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.

  PMID: 27099658 BACKGROUND

• 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.

  PMID: 29505098 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.

  PMID: 31210922 RESULT

• 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.

  PMID: 28774271 DERIVED

Related Links

• Study protocol published in Springer BMC Endocrine Disorders

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Mood Disorders

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Mental Disorders

Study Officials

• Boon-How Chew, MMed

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 6, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share