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A Community-Based Pilot Study on Enhancing Self-Care Behaviors and Blood Glucose Outcomes in Patients with Type 2 Diabetes in Vietnam

A Community-Based Pilot Study on Enhancing Self-Care Behaviors and Blood Glucose Outcomes in Patients with Type 2 Diabetes in Vietnam

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000997358
Enrollment
600
Registered
2026-08-13
Start date
2025-01-01
Completion date
2025-02-28
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Ethical approval for the study was obtained from the Biomedical Research Ethics Committee of Nam Dinh University of Nursing. Eligible participants were invited to participate in the program, provided informed consent, and were fully followed up before and after the intervention as well as after the follow-up period. Written informed consent will be obtained from all participants prior to enrollment. This study aim to analyze the effectiveness of an Active Self-Care Support Model to self-care behaviors of participants. The study hypothesizes that participants receiving the intervention will demonstrate better self-care practices and improved blood glucose outcomes compared to those receiving standard care.

Interventions

Through five sequential steps. Step 1. Provincial-level workshop A provincial-level workshop was organized approximately two weeks before the commencement of the intervention to standardize the technical content, implementation procedures, monitoring processes, and coordination mechanisms across the intervention sites. The workshop was organized and facilitated by the research team, including diabetes researchers, nursing faculty members from Nam Dinh University of Nursing, physicians with expe

Through five sequential steps. Step 1. Provincial-level workshop A provincial-level workshop was organized approximately two weeks before the commencement of the intervention to standardize the technical content, implementation procedures, monitoring processes, and coordination mechanisms across the intervention sites. The workshop was organized and facilitated by the research team, including diabetes researchers, nursing faculty members from Nam Dinh University of Nursing, physicians with experience in diabetes management, and representatives from local health authorities. Participants included commune-level healthcare workers, including physicians, nurses, and public health staff, representatives from district and commune health centers, and local coordinators responsible for intervention implementation. The workshop consisted of one face-to-face session lasting one day (8 hours). Step 2. Capacity-building activities Capacity-building activities constituted the core component of the intervention and were delivered during the first six weeks of the intervention period, immediately following the provincial-level workshop and the establishment of local implementation teams. The training courses were delivered by diabetes researchers, nursing educators, and healthcare professionals experienced in diabetes prevention and management. All training courses were conducted face-to-face at the intervention communes and involved commune-level healthcare workers, patients with type 2 diabetes mellitus, and their primary caregivers. A total of six training courses were delivered over approximately six weeks. Each course lasted 1.5 days, comprising a half-day theoretical session and a one-day practical session. Participants were encouraged to attend all sessions relevant to their roles. The training used a combination of lectures, educational videos, group discussions, practical demonstrations, simulated scenarios, and direct feedback from trainers. The capacity-building activities were conducted at commune health stations and community meeting venues across the three intervention communes: Nam Van Commune in Nam Dinh City, My Hung Commune in My Loc District, and Giao Hai Commune in Giao Thuy District. Intervention fidelity was monitored through attendance records, training completion checklists, and supervision visits conducted by the research team and commune health staff. Participant engagement was assessed through attendance at training sessions, participation in support group activities, and completion of follow-up assessments. Commune health staff maintained individual monitoring records to document participation and self-care practices throughout the intervention period. Step 3. Provision of educational materials, self-monitoring tools, and health communication videos Educational materials included printed booklets and leaflets covering diabetes knowledge, medication adherence, healthy eating, physical activity, blood glucose monitoring, and prevention of complications. These materials were specifically developed for this study based on its objectives and intervention content. Self-monitoring tools included self-care record forms and blood glucose monitoring logs. Health communication videos contained short educational messages demonstrating appropriate self-care behaviours and diabetes management practices. These materials were provided primarily to patients with type 2 diabetes mellitus and their caregivers. Printed materials were distributed directly during training sessions and follow-up activities. Educational videos were shown during training sessions and community meetings and were also made available through commune health stations for repeated viewing. Educational materials and self-monitoring tools were distributed once immediately after the training sessions, and participants were encouraged to use them continuously throughout the intervention period and the subsequent three-month follow-up period. Health communication videos were presented during training and reinforcement activities throughout the intervention. The intervention was implemented at commune health stations, community meeting venues, and within the local communities where participants lived in the intervention communes. Adherence was monitored through review of self-monitoring records, periodic counseling sessions, participation in support groups, and follow-up visits by commune health staff. Fidelity was assessed using implementation checklists and supervision reports completed by the research team. Step 4. Post-training support Post-training support was provided immediately after completion of the capacity-building activities and continued throughout the three-month follow-up period. The support consisted of community-based peer support groups, individual counseling sessions, small-group counseling sessions, and ongoing monitoring of blood glucose and self-care practices at commune health stations. These support activities were delivered by trained commune healthcare workers under the supervision of the research team. Post-training support was provided to patients with type 2 diabetes mellitus and, where appropriate, their caregivers. Support group meetings and counseling activities were conducted monthly during the three-month follow-up period after completion of the training courses. Step 5. Monitoring and evaluation Monitoring and evaluation were conducted at three time points: baseline, before the intervention; immediately after completion of the intervention; and three months after intervention completion as a follow-up assessment. The assessments included self-care behaviours measured using the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire, as well as selected clinical indicators, including blood glucose indices, blood pressure, and body mass index (BMI). Monitoring and evaluation were conducted throughout the five-month study period, including the intervention phase and the three-month follow-up phase. Baseline assessments were conducted before the commencement of the intervention, post-intervention assessments were conducted immediately after completion of the intervention, and follow-up assessments were conducted three months after intervention completion.

Sponsors

Nam Dinh university of Nursing
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

The study population consisted primarily of patients with type 2 diabetes mellitus living in Nam Dinh Province. Commune-level healthcare workers and caregivers participated only as intervention facilitators and support personnel and were not included as study participants for outcome assessment. The inclusion criteria for patients were: - Aged 18 years or older; - Diagnosed with type 2 diabetes mellitus for at least 6 months before study enrollment; - Living in the selected study communes; - Able to communicate and complete study questionnaires; - Willing to provide informed consent and participate in the study.

Exclusion criteria

Patients with serious physical or mental illnesses or those who were unable to participate in surveys

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 31, 2026