A Personalized Self-care Support Program for Primary Care Patients With Diabetic Foot Ulcer
NCT Number: NCT06540170
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Foot Ulcer
Interventions: BEHAVIORAL: A personalised self-care support program
Sponsor: National Healthcare Group Polyclinics
Collaborators: Lee Kong Chian School of Medicine, Nanyang Technological University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-12
Completion Date: 2025-08-10

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 6 weeks after their routine wound care dressing.

Primary Outcome Measures: 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., 3 months from baseline|Acceptability of the intervention, Participants will be interviewed to determine the acceptability of the intervention., 3 months from baseline
Secondary Outcome Measures: Patients' adherence to foot self-care behaviour, 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., Baseline and 3 months from baseline|Patients' foot care confidence (self-efficacy), 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., Baseline and 3 months from baseline|Patients' illness belief, 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., Baseline and 3 months from baseline|Patients' diabetes distress, 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., Baseline and 3 months from baseline|Patients' knowledge of recognizing wound deterioration, 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., Baseline and 3 months 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 (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., Baseline and 3 months 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), and indicated by patients' perceptions of HCP autonomy support being higher after receiving the personalized care program compares to the baseline., Baseline and 3 months from baseline