Type 2 Diabetes MellitusVEMOFITNCT02730078
Value-based Emotion-focused Educational Programme to Reduce Diabetes-related Distress
A study testing VEMOFIT and Attention-meetings (AG) in people with Type 2 Diabetes Mellitus, run by Universiti Putra Malaysia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- VEMOFIT and Attention-meetings (AG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- VEMOFIT, Attention-meetings (AG)
- Keywords
- Mood Disorders, Self Care, Primary Care
- Medical subject headings
- Diabetes Mellitus, Type 2, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEMOFITBehavioural
Also called Value-based emotion-focused educational programme
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Attention-meetings (AG) | Active comparator | Attention-control Receives: Behavioral: Attention-meetings (AG) |
| VEMOFIT (VG) | Experimental | Personal value exploration, disease education, emotional skills and goal setting. Receives: Behavioral: VEMOFIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes-related distress
Measured with the 17-item Diabetes Distress Scale (DDS-17)
Measured: 6-week (immediate post-intervention) [T1]
Diabetes-related distress
Measured with the 17-item Diabetes Distress Scale (DDS-17)
Measured: 6-month [T2]
Diabetes-related distress
Measured with the 17-item Diabetes Distress Scale (DDS-17)
Measured: 12-month [T3]
Secondary outcomes (26)
Depression
Measured with the Patient Health Questionnaire (PHQ-9)
Measured: 6-week (immediate post-intervention) [T1]
Depression
Measured with the Patient Health Questionnaire (PHQ-9)
Measured: 6-month [T2]
Depression
Measured with the Patient Health Questionnaire (PHQ-9)
Measured: 12-month [T3]
Illness perception
Measured with the Brief Illness Perception Questionnaire (BIPQ)
Measured: 6-week (immediate post-intervention) [T1]
Illness perception
Measured with the Brief Illness Perception Questionnaire (BIPQ)
Measured: 6-month [T2]
Illness perception
Measured with the Brief Illness Perception Questionnaire (BIPQ)
Measured: 12-month [T3]
Quality of life
Measured with the WHOQOL-BREF
Measured: 6-month [T2]
Quality of life
Measured with the WHOQOL-BREF
Measured: 12-month [T3]
Self-efficacy
Measured by the Diabetes Management Self Efficacy Scale (DMSES)
Measured: 6-week (immediate post-intervention) [T1]
Self-efficacy
Measured by the Diabetes Management Self Efficacy Scale (DMSES)
Measured: 6-month [T2]
Self-efficacy
Measured by the Diabetes Management Self Efficacy Scale (DMSES)
Measured: 12-month [T3]
Self-care behaviours
Measured with the Diabetes Self-Care Activities (SDSCA) scale
Measured: 6-week (immediate post-intervention) [T1]
Self-care behaviours
Measured with the Diabetes Self-Care Activities (SDSCA) scale
Measured: 6-month [T2]
Self-care behaviours
Measured with the Diabetes Self-Care Activities (SDSCA) scale
Measured: 12-month [T3]
Positive emotions
Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD)
Measured: 6-week (immediate post-intervention) [T1]
Positive emotions
Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD)
Measured: 6-month [T2]
Positive emotions
Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD)
Measured: 12-month [T3]
HbA1c
Measured: 6-week (immediate post-intervention) [T1]
HbA1c
Measured: 6-month [T2]
HbA1c
Measured: 12-month [T3]
Blood pressure
systolic and diastolic blood pressure
Measured: 6-week (immediate post-intervention) [T1]
Blood Pressure
systolic and diastolic blood pressure
Measured: 6-month [T2]
Blood pressure
systolic and diastolic blood pressure
Measured: 12-month [T3]
LDL-cholesterol
lipid profiles
Measured: 6-week (immediate post-intervention) [T1]
LDL-cholesterol
lipid profiles
Measured: 6-month [T2]
LDL-cholesterol
lipid profiles
Measured: 12-month [T3]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Malaysia, UMC Utrecht
- Responsible party
- Principal investigator, Boon-How Chew, Universiti Putra Malaysia
- Investigators
- Boon-How Chew, MMed, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730078
- Sponsor's protocol ID
- NMRR- 15-1144-24803
- Acronym
- VEMOFIT
- Status last verified
- Jul 2019
- First submitted
- 29 Mar 2016
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Anonymous data will be accessible publicly via the figshare.
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.
PubMed 28376921Chew 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.
PubMed 28954185Chew 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.
PubMed 29765258Chew 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.
PubMed 25512782Chew 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.
PubMed 27099658Chew 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.
PubMed 29505098Chew 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.
PubMed 31210922Chew 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.
PubMed 28774271
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02730078
- Acronym / sponsor ID
- VEMOFIT / NMRR- 15-1144-24803
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Mood Disorders, Self Care, Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- Ministry of Health, Malaysia, UMC Utrecht
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention-meetings (AG) | Active comparator | Behavioral: Attention-meetings (AG)Attention-control |
| VEMOFIT (VG) | Experimental | Behavioral: VEMOFITPersonal value exploration, disease education, emotional skills and goal setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VEMOFITAlso: Value-based emotion-focused educational programmeThe 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. | Behavioural | VEMOFIT (VG) |
| 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. | Behavioural | Attention-meetings (AG) |
Primary outcome
Diabetes-related distress
Time frame: 6-week (immediate post-intervention) [T1]
Measured with the 17-item Diabetes Distress Scale (DDS-17)
Diabetes-related distress
Time frame: 6-month [T2]
Measured with the 17-item Diabetes Distress Scale (DDS-17)
Diabetes-related distress
Time frame: 12-month [T3]
Measured with the 17-item Diabetes Distress Scale (DDS-17)
26 secondary outcomes
Depression
Time frame: 6-week (immediate post-intervention) [T1]
Depression
Time frame: 6-month [T2]
Depression
Time frame: 12-month [T3]
Illness perception
Time frame: 6-week (immediate post-intervention) [T1]
Illness perception
Time frame: 6-month [T2]
Illness perception
Time frame: 12-month [T3]
Quality of life
Time frame: 6-month [T2]
Quality of life
Time frame: 12-month [T3]
Self-efficacy
Time frame: 6-week (immediate post-intervention) [T1]
Self-efficacy
Time frame: 6-month [T2]
Self-efficacy
Time frame: 12-month [T3]
Self-care behaviours
Time frame: 6-week (immediate post-intervention) [T1]
Self-care behaviours
Time frame: 6-month [T2]
Self-care behaviours
Time frame: 12-month [T3]
Positive emotions
Time frame: 6-week (immediate post-intervention) [T1]
Positive emotions
Time frame: 6-month [T2]
Positive emotions
Time frame: 12-month [T3]
HbA1c
Time frame: 6-week (immediate post-intervention) [T1]
HbA1c
Time frame: 6-month [T2]
HbA1c
Time frame: 12-month [T3]
Blood pressure
Time frame: 6-week (immediate post-intervention) [T1]
Blood Pressure
Time frame: 6-month [T2]
Blood pressure
Time frame: 12-month [T3]
LDL-cholesterol
Time frame: 6-week (immediate post-intervention) [T1]
LDL-cholesterol
Time frame: 6-month [T2]
LDL-cholesterol
Time frame: 12-month [T3]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Background: PubMed 28376921Chew 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.
- Background: PubMed 28954185Chew 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.
- Background: PubMed 29765258Chew 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.
- Background: PubMed 25512782Chew 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.
- Background: PubMed 27099658Chew 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.
- Results publication: PubMed 29505098Chew 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.
- Results publication: PubMed 31210922Chew 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.
- Derived from this study: PubMed 28774271Chew 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.
- Study protocol published in Springer BMC Endocrine DisordersLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymous data will be accessible publicly via the figshare.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boon-How Chew, MMed principal investigator
Universiti Putra Malaysia
Questions about this trial
What is this clinical trial studying?
A study testing VEMOFIT and Attention-meetings (AG) in people with Type 2 Diabetes Mellitus, run by Universiti Putra Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes-related distress (time frame: 6-week (immediate post-intervention) [T1]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02730078, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019; AzTrials last refreshed its copy on 28 Oct 2026.