Clinical trial NCT06540170: A Personalized Self-care Support Program for Primary Care Patients with Diabetic Foot Ulcer
Official title: Feasibility and Acceptability of a Personalized Self-care Support Program for Primary Care Patients with Diabetic Foot Ulcer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Foot Ulcer
Keywords: Diabetic foot ulcer
self-care support
Motivational interviewing
Lead sponsor: National Healthcare Group Polyclinics
Sponsor class: OTHER_GOV
Collaborators: name: Nanyang Technological University
First posted: 2024-08-06
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-group pre-intervention and post-intervention comparison
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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 1-2 weeks within 3-6 weeks after their routine wound care dressing.

Detailed 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 3-6 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 three-month retention of participants from enrolment, or 2-4 weeks retention from the last intervention session, whichever comes first, 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 12 from enrolment, or week 2-4 from the last intervention session, whichever comes first (end of the study) from enrolment to reveal any differences in PROMs and clinical outcomes. Differences in PROMs between baseline and week 12 from enrolment, or week 2-4 from the last intervention session, whichever comes first, 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

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of recruiting and retaining
timeFrame: 3 months from baseline, or 2-4 weeks from the last intervention session, whichever comes first.
measure: Acceptability of the intervention
timeFrame: 3 months from baseline, or 2-4 weeks from the last intervention session, whichever comes first.
Secondary outcomes:
measure: Patients&#39; adherence to foot self-care behaviour
timeFrame: Baseline and 3 months from baseline, or 2-4 weeks from the last intervention, whichever comes first.
measure: Patients&#39; foot care confidence (self-efficacy)
timeFrame: Baseline and 3 months from baseline, or 2-4 weeks from the last intervention, whichever comes first.
measure: Patients&#39; illness belief
timeFrame: Baseline and 3 months from baseline, or 2-4 weeks from the last intervention, whichever comes first.
measure: Patients&#39; perceptions of autonomy support
timeFrame: Baseline and 3 months from baseline, or 2-4 weeks from the last intervention, whichever comes first.
measure: Patients&#39; diabetes distress
timeFrame: Baseline and 3 months from baseline, or 2-4 weeks from the last intervention, whichever comes first.
measure: Patients&#39; knowledge of recognizing wound deterioration
timeFrame: Baseline and 3 months from baseline, or 2-4 weeks from the last intervention, whichever comes first.
measure: Patients&#39; quality of life
timeFrame: Baseline and 3 months from baseline, or 2-4 weeks from the last intervention, whichever comes first.
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Healthcare Group Polyclinics
Study officials:
affiliation: National Healthcare Group Polyclinics Singapore
name: Julia Xiaoli Zhu
role: PRINCIPAL_INVESTIGATOR
References: