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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
29
A personalized care program consists of three 30-minute face-to-face sessions (once every 2 weeks) after patients' routine wound dressings to enhance self-efficacy, support emotional adjustments, and DFU self-care.
National Healthcare Group Polyclinics
Singapore, Singapore
Feasibility of Recruiting and Retaining
The number of patients recruited to the study and retained at the end of the study period will be documented.
Time frame: 4 weeks post-intervention from baseline.
Acceptability of the Intervention
Participants will be interviewed to determine the acceptability of the intervention.
Time frame: 4 weeks post-intervention from baseline.
Patients' Adherence to Foot Self-care Behaviour
Measured using the 7-item Diabetes Foot Self-Care Behavior Scale. All items on the scale are rated on a 5-point Likert-type scale. The higher scores represent better foot self-care behaviors. The minimum value is 7 and the maximum is 35.
Time frame: 4 weeks post-intervention from baseline.
Patients' Foot Care Confidence (Self-efficacy)
Measured using the 12-item Foot Care Confidence Scale. All items on the scale are rated on a 5-point Likert-type scale. The higher scores represent better foot care confidence. The minimum value is 12 and the maximum value is 60.
Time frame: 4 weeks post-intervention from baseline.
Patients' Illness Belief
Measured using the 8-item Brief Illness Perception Questionnaire, each item is rated on a 0-10 scale, with higher scores indicating a more threatening perception of the illness. The total score is calculated by summing the scores of all eight items where items 3, 4, and 7 are inversed. The possible range of scores is 0 (minimum value)-80 (maximum value). Higher scores indicate worse illness perception.
Time frame: 4 weeks post-intervention from baseline.
Patients' Perceptions of Autonomy Support
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). The minimum value is 1 and the maximum value is 7. The higher score represents greater autonomy support.
Time frame: 4 weeks post-intervention from baseline.
Patients' Diabetes Distress
Measured using Diabetes Distress Scale 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. The minimum value is 1 and the maximum value is 6. The higher score indicates greater distress.
Time frame: 4 weeks post-intervention from baseline.
Patients' Knowledge of Recognizing Wound Deterioration
Measured using Warning Signs of Diabetic Foot Ulcer Deterioration Questionnaire comprising of 12 items. Each item with the correct answer obtains a score of 1. The minimum score is 0 and the maximum value is 12. The higher scores represent better knowledge.
Time frame: 4 weeks post-intervention from baseline.
Patients' Quality of Life
Measured using EQ-5D-5L that is self-reported by patients and consists of two parts: a descriptive system and a visual analogue scale. The visual analogue scale for imaginative health state is used for the pilot study. The minimum value is 0 and the maximum value is 100. The higher score represents the better 0 imaginative health state.
Time frame: 4 weeks post-intervention from baseline.
HbA1c
HbA1c for participants who have completed the program.
Time frame: 4 weeks post-intervention from baseline.
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