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Completed

NCT Number: NCT06540170

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.

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Key information

Conditions

Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Healthcare Group Polyclinics

Singapore

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A personalised self-care support program

Behavioral

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.

Primary outcomes

  1. Feasibility of Recruiting and Retaining

    Time frame: 4 weeks post-intervention from baseline.

    The number of patients recruited to the study and retained at the end of the study period will be documented.

  2. Acceptability of the Intervention

    Time frame: 4 weeks post-intervention from baseline.

    Participants will be interviewed to determine the acceptability of the intervention.

Secondary outcomes

  1. Patients' Adherence to Foot Self-care Behaviour

    Time frame: 4 weeks post-intervention from baseline.

    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.

  2. Patients' Foot Care Confidence (Self-efficacy)

    Time frame: 4 weeks post-intervention from baseline.

    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.

  3. Patients' Illness Belief

    Time frame: 4 weeks post-intervention from baseline.

    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. Patients' Perceptions of Autonomy Support

    Time frame: 4 weeks post-intervention from baseline.

    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.

  5. Patients' Diabetes Distress

    Time frame: 4 weeks post-intervention from baseline.

    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.

  6. Patients' Knowledge of Recognizing Wound Deterioration

    Time frame: 4 weeks post-intervention from baseline.

    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.

  7. Patients' Quality of Life

    Time frame: 4 weeks post-intervention from baseline.

    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.

  8. HbA1c

    Time frame: 4 weeks post-intervention from baseline.

    HbA1c for participants who have completed the program.

Sponsors and collaborators

Lead sponsor

National Healthcare Group Polyclinics

Other Gov

Collaborators

  • Nanyang Technological University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 6, 2024
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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