NCT05602441

Brief Summary

Insufficient self-management is a significant barrier for people with type 2 diabetes (T2D) to achieve glycemic control and reduce the risk of acute and long-term diabetes complications which negatively affect the quality of life and increase the risk of diabetes-related death. This pre-post study aimed to evaluate the impact of a peer-based club intervention to improve self-management among people living with T2D in two rural communities in Vietnam.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
229

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

12 months

First QC Date

September 15, 2022

Last Update Submit

November 1, 2022

Conditions

Diabete Type 2

Outcome Measures

Primary Outcomes (1)

  • Change in glycated haemoglobin from baseline to 12 months post intervention

    HbA1c goal for adults is 7 % or less

    Baseline and 12 months post intervention

Secondary Outcomes (13)

  • Change in medication adherence -Morisky Medication Adherence Scale-8 (MMAS-8) from baseline

    Start intervention and 12 months post intervention

  • Change in body mass index - BMI from baseline

    Baseline and 12 months post intervention

  • Change in mental health Self Reporting Questionnaire 20-Item (SRQ-20) from baseline

    Baseline and 12 months post intervention

  • Change in systolic blood pressure from baseline

    Baseline and 12 months post intervention

  • Change in diastolic blood pressure from baseline

    Baseline and 12 months post intervention

  • +8 more secondary outcomes

Study Arms (1)

VALID - diabetes supportive clubs

EXPERIMENTAL

VALID - diabetes supportive clubs

Behavioral: VALID - diabetes supportive clubs

Interventions

VALID - diabetes supportive clubsBEHAVIORAL

The VALID - diabetes supportive clubs comprised diabetes classes and diabetes clubs, to highlight two prominent aspects of diabetes self-management: education and peer support. The diabetes club meeting was held twice a month during a 9-month intervention, consisting of a focused delivery of the knowledge and discussion following the topic in the monthly class. Club meetings also included dedicated time for blood glucose testing and sharing experiences to deal with the difficulties of the periodic insurance examinations process. Finally, the club meetings provided the participants with emotional support to deal with the stigma and sadness in their daily lives. Core messages aimed to strengthen daily self-management and boost the spiritual bond between individuals with T2D toward a healthy, happy life with T2DM. In addition, the intervention aimed to strengthen the capacities of grassroots health care workers in diabetes consultations and communication in rural communities.

VALID - diabetes supportive clubs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals diagnosed with or treated for T2D over 18 years old
  • Residing in two selected communes
  • Without acute and/or severe illness
  • Able to answer the questionnaire completely
  • Agreed to participate voluntarily
  • Participated in both pre - post-study and the intervention program.

You may not qualify if:

  • Refusal to continue participating in study
  • Migration
  • Illness or hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thai Binh University of Medicine and Pharmacy

Thái Bình, 410000, Vietnam

Location

Related Publications (1)

  • Dang NT, Phong Vu T, M Gammeltoft T, Christian Bygbjerg I, W Meyrowitsch D, Sondergaard J. Pre-/-post-analyses of a feasibility study of a peer-based club intervention among people living with type 2 diabetes in Vietnam's rural communities. PLoS One. 2023 Nov 28;18(11):e0290355. doi: 10.1371/journal.pone.0290355. eCollection 2023.

    PMID: 38015901DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Pilot intervention study with pre- and post assessment of effects
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Head of Health mangement Department

Study Record Dates

First Submitted

September 15, 2022

First Posted

November 2, 2022

Study Start

January 12, 2021

Primary Completion

January 11, 2022

Study Completion

May 31, 2023

Last Updated

November 2, 2022

Record last verified: 2022-10

Locations

VN(1)