A Personalized Self-care Support Program for Primary Care Patients with Diabetic Foot Ulcer
- Conditions
- Foot Ulcer
- Interventions
- Behavioral: A personalised self-care support program
- Registration Number
- NCT06540170
- Lead Sponsor
- National Healthcare Group Polyclinics
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm A personalised self-care support program Eligible and willing participants will be invited to participate in the program and receive three 30-minute face-to-face sessions (once every 1-2 weeks) within 6 weeks from the enrolment.
- Primary Outcome Measures
Name Time Method Feasibility of recruiting and retaining 3 months from baseline, or 2-4 weeks from the last intervention session, whichever comes first. The number of patients recruited to the study and retained at the end of the study period will be documented.
Acceptability of the intervention 3 months from baseline, or 2-4 weeks from the last intervention session, whichever comes first. Participants will be interviewed to determine the acceptability of the intervention.
- Secondary Outcome Measures
Name Time Method Patients' adherence to foot self-care behaviour Baseline and 3 months from baseline, or 2-4 weeks from the last intervention, whichever comes first. Measured using the 7-item Diabetes Foot Self-Care Behavior Scale (DFSBS). All items on the scale are rated on a 5-point Likert-type scale with the higher scores represented better foot self-care behaviors. The total DFSBS score ranges 7-35.
Patients' foot care confidence (self-efficacy) Baseline and 3 months from baseline, or 2-4 weeks from the last intervention, whichever comes first. Measured using the 12-item Foot Care Confidence Scale (FCCS). All items on the scale are rated on a 5-point Likert-type scale with the higher scores represented better foot care confidence. The total FCCS score ranges 12-60.
Patients' illness belief Baseline and 3 months from baseline, or 2-4 weeks from the last intervention, whichever comes first. Measured using the 12-item Brief Illness Perception Questionnaire (BIPQ) consisting of eight illness representation items that are rated on a 0 to 10 ordinal scale, higher scores on the consequences, identity, timeline, concern and emotional representations indicate higher perceived threat, whereas higher scores on the treatment control, personal control, and illness coherence items indicate higher perceived control.
Patients' perceptions of autonomy support Baseline and 3 months from baseline, or 2-4 weeks from the last intervention, whichever comes first. Measured using the 6-item Health Care Climate Questionnaire that patients rate items on a 7-point Likert scale (1 = not at all true, 7 = very true), and indicated by patients\' perceptions of HCP autonomy support being higher after receiving the personalized care program compares to the baseline.
Patients' diabetes distress Baseline and 3 months from baseline, or 2-4 weeks from the last intervention, whichever comes first. Measured using Diabetes Distress Scale (DDS) consists of 17 items with four subscales including emotional burden, physician-related distress, regimen-related distress, and interpersonal distress. All items were rated on a 6-point Likert scale where a higher score indicates greater distress.
Patients' knowledge of recognizing wound deterioration Baseline and 3 months from baseline, or 2-4 weeks from the last intervention, whichever comes first. Measured using Warning Signs of Diabetic Foot Ulcer Deterioration Questionnaire (WS-DFUD-KQ) comprises of 12 items. Three of the 12 items are negatively worded and state as misconceptions regarding warning signs of diabetic foot ulcer deterioration (i.e. item 8, 9, 10). The response choices include \"yes,\" \"no,\" and \"uncertain.\" Each item with the correct answer obtains a score of 1, after which the scores are summed to obtain a total score. The higher scores represent better knowledge. The total WS-DFUD-KQ score ranges 0-12.
Patients' quality of life Baseline and 3 months from baseline, or 2-4 weeks from the last intervention, whichever comes first. Measured using EQ-5D-5L that is self-reported by patients and consists of two parts: a descriptive system and a visual analogue scale (VAS). The descriptive system contains questions relating to five domains of health, namely, mobility, self-care, usual activities, pain/discomfort and anxiety/depression. There are five levels to each question ranging from 'no problems', 'slight problems', 'moderate problems', 'severe problems' to 'extreme problems' or 'unable to'. The VAS is a 20 cm long vertical line that ranges from 'worst imaginative health state' set at 0 to 'best imaginable health state' set at 100, where respondents rate their current health status.
Trial Locations
- Locations (1)
National Healthcare Group Polyclinics
🇸🇬Singapore, Singapore