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

July 10, 2019 updated by: Boon-How Chew, Universiti Putra Malaysia

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diabetes-related distress
Time Frame: 6-week (immediate post-intervention) [T1]
Measured with the 17-item Diabetes Distress Scale (DDS-17)
6-week (immediate post-intervention) [T1]
Diabetes-related distress
Time Frame: 6-month [T2]
Measured with the 17-item Diabetes Distress Scale (DDS-17)
6-month [T2]
Diabetes-related distress
Time Frame: 12-month [T3]
Measured with the 17-item Diabetes Distress Scale (DDS-17)
12-month [T3]

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: 6-week (immediate post-intervention) [T1]
Measured with the Patient Health Questionnaire (PHQ-9)
6-week (immediate post-intervention) [T1]
Depression
Time Frame: 6-month [T2]
Measured with the Patient Health Questionnaire (PHQ-9)
6-month [T2]
Depression
Time Frame: 12-month [T3]
Measured with the Patient Health Questionnaire (PHQ-9)
12-month [T3]
Illness perception
Time Frame: 6-week (immediate post-intervention) [T1]
Measured with the Brief Illness Perception Questionnaire (BIPQ)
6-week (immediate post-intervention) [T1]
Illness perception
Time Frame: 6-month [T2]
Measured with the Brief Illness Perception Questionnaire (BIPQ)
6-month [T2]
Illness perception
Time Frame: 12-month [T3]
Measured with the Brief Illness Perception Questionnaire (BIPQ)
12-month [T3]
Quality of life
Time Frame: 6-month [T2]
Measured with the WHOQOL-BREF
6-month [T2]
Quality of life
Time Frame: 12-month [T3]
Measured with the WHOQOL-BREF
12-month [T3]
Self-efficacy
Time Frame: 6-week (immediate post-intervention) [T1]
Measured by the Diabetes Management Self Efficacy Scale (DMSES)
6-week (immediate post-intervention) [T1]
Self-efficacy
Time Frame: 6-month [T2]
Measured by the Diabetes Management Self Efficacy Scale (DMSES)
6-month [T2]
Self-efficacy
Time Frame: 12-month [T3]
Measured by the Diabetes Management Self Efficacy Scale (DMSES)
12-month [T3]
Self-care behaviours
Time Frame: 6-week (immediate post-intervention) [T1]
Measured with the Diabetes Self-Care Activities (SDSCA) scale
6-week (immediate post-intervention) [T1]
Self-care behaviours
Time Frame: 6-month [T2]
Measured with the Diabetes Self-Care Activities (SDSCA) scale
6-month [T2]
Self-care behaviours
Time Frame: 12-month [T3]
Measured with the Diabetes Self-Care Activities (SDSCA) scale
12-month [T3]
Positive emotions
Time Frame: 6-week (immediate post-intervention) [T1]
Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD)
6-week (immediate post-intervention) [T1]
Positive emotions
Time Frame: 6-month [T2]
Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD)
6-month [T2]
Positive emotions
Time Frame: 12-month [T3]
Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD)
12-month [T3]
HbA1c
Time Frame: 6-week (immediate post-intervention) [T1]
6-week (immediate post-intervention) [T1]
HbA1c
Time Frame: 6-month [T2]
6-month [T2]
HbA1c
Time Frame: 12-month [T3]
12-month [T3]
Blood pressure
Time Frame: 6-week (immediate post-intervention) [T1]
systolic and diastolic blood pressure
6-week (immediate post-intervention) [T1]
Blood Pressure
Time Frame: 6-month [T2]
systolic and diastolic blood pressure
6-month [T2]
Blood pressure
Time Frame: 12-month [T3]
systolic and diastolic blood pressure
12-month [T3]
LDL-cholesterol
Time Frame: 6-week (immediate post-intervention) [T1]
lipid profiles
6-week (immediate post-intervention) [T1]
LDL-cholesterol
Time Frame: 6-month [T2]
lipid profiles
6-month [T2]
LDL-cholesterol
Time Frame: 12-month [T3]
lipid profiles
12-month [T3]

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health-care utilisation/hospitalisation
Time Frame: 6-month [T2]
Number of visits to healthcare facilities including hospitalisation, patient's record and diary used in the study
6-month [T2]
Health-care utilisation/hospitalisation
Time Frame: 12-month [T3]
Number of visits to healthcare facilities including hospitalisation, patient's record and diary used in the study
12-month [T3]
Adverse event
Time Frame: 6-week (immediate post-intervention) [T1]
Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary
6-week (immediate post-intervention) [T1]
Adverse event
Time Frame: 6-month [T2]
Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary
6-month [T2]
Adverse event
Time Frame: 12-month [T3]
Number of hypoglycaemia and extreme negative emotions as recorded in participant's diary
12-month [T3]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiti Putra Malaysia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
UMC Utrecht
Ministry of Health, Malaysia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Boon-How Chew, MMed, Universiti Putra Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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