A Personalized Self-care Support Program for Primary Care Patients With Diabetic Foot Ulcer

National Healthcare Group Polyclinics

Status: Completed

Conditions: Foot Ulcer

Treatments: Behavioral: A personalised self-care support program

Study type: Interventional

Funder types: Other

Identifiers

NCT06540170

2022/00895

Details and patient eligibility

About

This clinical trial aims to learn if a personalized self-care program supporting self-care and Healing through Empowerment and Active Listening (HEALing), is acceptable to patients with diabetic foot ulcer (DFU) and wound care nurses, and is feasible to deliver supportive self-care for primary care patients living with DFU.

The main questions it aims to answer are:

• Is the personalized self-care improvement program acceptable to patients with diabetic foot ulcer (DFU) and wound care nurses to deliver?
• Is the personalized self-care improvement program feasible for supportive self-care for primary care patients living with DFU? Researchers will compare pre-intervention to post-intervention to see if the personalized self-care improvement program works to support self-care management for patients with DFU.

Participants will:

-receive three 30-minute face-to-face intervention sessions every 2 weeks within 6 weeks after their routine wound care dressing.

Full description

This study aims to assess the potential benefit(s) of a personalized intervention integrating motivational interviewing (MI) with positive psychological skills for supportive self-care among patients with diabetic foot ulcers.

A single-arm pilot feasibility study using a mixed-method approach will be conducted between Aug 2024 and February 2025. 30 participants will be recruited from nurse-led wound clinics in a large primary care sector and selected according to the inclusion criteria. Participants will receive three 30-minute face-to-face sessions of an MI-based personalized care program over 6 weeks to support DFU self-care coping behaviors.

The primary outcomes include the feasibility of recruitment and the acceptability of the proposed personalized intervention. Feasibility will be assessed based on recruitment and 4 weeks retention of participants from last intervention session through examination of screening logs and follow-up completion. Acceptability to patients and healthcare professionals (HCPs) will be evaluated using semi-structured individual interviews.

The secondary outcomes include patient-reported outcome measures (PROM) consisting of DFU self-care behaviors, self-efficacy, psychological determinants, and clinical endpoints such as foot skin conditions and glycemic control (measured by HbA1C). The results will be evaluated by comparing baseline and post-intervention data collected at week 0 and week 4 from last intervention session, for any differences in PROMs and clinical outcomes. Differences in PROMs between the two time points will be assessed using univariable analyses such as the chi-square test for categorical variables and independent samples t-test or analysis of variance (ANOVA) for continuous variables where appropriate.

Semi-structured face-to-face individual qualitative interviews will be conducted at the end of the pilot trial to provide insight into peoples' experiences of participation in the intervention. Data will be analyzed thematically.

Enrollment: 29 patients

Sex: All

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with diabetes and DFU aged 21 years or above receiving treatment and wound care at National Healthcare Group Polyclinics
• HCPs, who are aged 21 years or above with a patient-facing role working in delivering program (only for qualitative interviews)

Exclusion criteria

• Patients have a diagnosis of critical lower limb ischemia, active osteomyelitis, Charcot foot, cognitive/psychiatric diagnoses, and hearing or vision impairment.
• Pregnant women will be excluded from the study for both patient and HCP groups

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Single arm

Other group

Description:

Eligible and willing participants will be invited to participate in the program and receive three 30-minute face-to-face sessions (once every 2 weeks) within 6 weeks of enrolment.

Treatment:

Behavioral: A personalised self-care support program