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Effectiveness of Self- and Family Management Support Combined mHealth Program on Functional, Self-Management Behaviors, and Family-Related Outcomes in Individuals with Peripheral Arterial Occlusive Disease Post-Revascularization: A Randomized Controlled Trial

Effectiveness of Self- and Family Management Support Combined mHealth Program on Functional, Self-Management Behaviors, and Family-Related Outcomes in Individuals with Peripheral Arterial Occlusive Disease Post-Revascularization: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251219002
Enrollment
56
Registered
2025-12-19
Start date
2026-01-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Peripheral arterial occlusive disease (PAOD) in individuals following revascularization Peripheral arterial occlusive disease Self- and family management support mHealth program Functional outcomes Self-management behaviors Family-related outcomes

Interventions

The SFMS-mHP is an eight-week structured program designed to improve patient self-management after revascularization and to strengthen supportive roles of family members. The program targets foot care
Experimental Behavioral,No Intervention No treatment
Self and Family Management Support program combined with mHealth ,Usual care

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: For individuals with PAOD: 1. Age >= 18 years 2. Diagnosed with PAOD and completed revascularization (endovascular, surgical, or hybrid) with full wound healing confirmed by a physician 3. Owns an Android smartphone, proficient in its use, able to operate mobile applications, with reliable internet access 4. Has a family member providing regular care and support 5. Able to communicate in Thai 6. Age >= 60 years: intact cognitive function (Mini-Cog score > 3) For family members: 1. Co-resides with the patient and serves as primary caregiver, assisting with diet, medication adherence, and follow-up appointments 2. Able to use mobile applications 3. Able to communicate in Thai 4. Age >= 60 years: intact cognitive function (Mini-Cog score > 3)

Exclusion criteria

Exclusion criteria: For individuals with PAOD: 1. Unable to ambulate independently or with assistive devices due to severe lower-limb impairment (e.g., paralysis, severe joint disease, profound neuropathy, wheelchair dependence) 2. Major lower-extremity amputation (below- or above-knee) 3. Exercise contraindications from comorbidities (e.g., unstable angina, recent myocardial infarction, stroke) or disease progression (e.g., new wounds, rest pain, restenosis) For family members: None specified

Design outcomes

Primary

MeasureTime frame
Self-management behaviors baseline, Week 8, Week 12 the Self-Management in PAOD Questionnaire ,Functional ability baseline, Week 12 6-Minute Walk Test ,Functional ability baseline, Week 8, Week 12 Walking Impairment Questionnaire,Vascular capacity baseline, Week 12 Ankle Brachial Index (ABI) and Toe Brachial Index (TBI)

Secondary

MeasureTime frame
Family function baseline, Week 12 Family APGAR ,Supportive family behaviors baseline, Week 12 Caregivers Behavior in Caring for Patients with PAOD Questionnaire,Patient and family satisfaction Week 12 the Satisfaction with Nursing Program Questionnaire

Countries

Thailand

Contacts

Public ContactSirirat Tanyabut

Ramathibodi Hospital

sirirat.tay@mahidol.ac.th022012670

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026