Clinical trial NCT02730078: Value-based Emotion-focused Educational Programme to Reduce Diabetes-related Distress
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Mood Disorders
Self Care
Primary Care
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Malaysia
name: UMC Utrecht
First posted: 2016-04-06
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diabetes-related distress
timeFrame: 6-week (immediate post-intervention) [T1]
measure: Diabetes-related distress
timeFrame: 6-month [T2]
measure: Diabetes-related distress
timeFrame: 12-month [T3]
Secondary outcomes:
measure: Depression
timeFrame: 6-week (immediate post-intervention) [T1]
measure: Depression
timeFrame: 6-month [T2]
measure: Depression
timeFrame: 12-month [T3]
measure: Illness perception
timeFrame: 6-week (immediate post-intervention) [T1]
measure: Illness perception
timeFrame: 6-month [T2]
measure: Illness perception
timeFrame: 12-month [T3]
measure: Quality of life
timeFrame: 6-month [T2]
measure: Quality of life
timeFrame: 12-month [T3]
measure: Self-efficacy
timeFrame: 6-week (immediate post-intervention) [T1]
measure: Self-efficacy
timeFrame: 6-month [T2]
measure: Self-efficacy
timeFrame: 12-month [T3]
measure: Self-care behaviours
timeFrame: 6-week (immediate post-intervention) [T1]
measure: Self-care behaviours
timeFrame: 6-month [T2]
measure: Self-care behaviours
timeFrame: 12-month [T3]
measure: Positive emotions
timeFrame: 6-week (immediate post-intervention) [T1]
measure: Positive emotions
timeFrame: 6-month [T2]
measure: Positive emotions
timeFrame: 12-month [T3]
measure: HbA1c
timeFrame: 6-week (immediate post-intervention) [T1]
measure: HbA1c
timeFrame: 6-month [T2]
measure: HbA1c
timeFrame: 12-month [T3]
measure: Blood pressure
timeFrame: 6-week (immediate post-intervention) [T1]
measure: Blood Pressure
timeFrame: 6-month [T2]
measure: Blood pressure
timeFrame: 12-month [T3]
measure: LDL-cholesterol
timeFrame: 6-week (immediate post-intervention) [T1]
measure: LDL-cholesterol
timeFrame: 6-month [T2]
measure: LDL-cholesterol
timeFrame: 12-month [T3]
Other outcomes:
measure: Health-care utilisation/hospitalisation
timeFrame: 6-month [T2]
measure: Health-care utilisation/hospitalisation
timeFrame: 12-month [T3]
measure: Adverse event
timeFrame: 6-week (immediate post-intervention) [T1]
measure: Adverse event
timeFrame: 6-month [T2]
measure: Adverse event
timeFrame: 12-month [T3]
Locations:
Study officials:
affiliation: Universiti Putra Malaysia
name: Boon-How Chew, MMed
role: PRINCIPAL_INVESTIGATOR
References:
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.
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(9):CD011469. doi: 10.1002/14651858.CD011469.pub2.
citation: 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.
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.
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.
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;35(6):750-759. doi: 10.1111/dme.13615. Epub 2018 Mar 30.
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 randomized controlled trial. Ther Adv Endocrinol Metab. 2019 May 31;10:2042018819853761. doi: 10.1177/2042018819853761. eCollection 2019.
citation: 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.