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

Feasibility and Acceptability of a Personalized Self-care Support Program for Primary Care Patients With Diabetic Foot Ulcer

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.

Study Overview

• Status: Completed
• Conditions: Foot Ulcer
• Intervention / Treatment: Behavioral: A personalised self-care support program

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 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
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • National Healthcare Group Polyclinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single arm; 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.	Behavioral: A personalised self-care support program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks post-intervention from baseline.
Acceptability of the Intervention	Participants will be interviewed to determine the acceptability of the intervention.	4 weeks post-intervention from baseline.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	4 weeks post-intervention from baseline.
HbA1c	HbA1c for participants who have completed the program.	4 weeks post-intervention from baseline.

Collaborators and Investigators

• Sponsor: National Healthcare Group Polyclinics
• Collaborators: Nanyang Technological University
• Investigators: Principal Investigator: Julia Xiaoli Zhu, National Healthcare Group Polyclinics Singapore

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2024
• Primary Completion (Actual): January 11, 2025
• Study Completion (Actual): January 11, 2025

Study Registration Dates

• First Submitted: July 27, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Motivational interviewing; Diabetic foot ulcer; self-care support
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Diseases; Skin and Connective Tissue Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: 2022/00895

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No