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| Name | Class |
|---|---|
| Nanyang Technological University | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Xiaoli Zhu | National Healthcare Group Polyclinics Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Healthcare Group Polyclinics | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41062140 | Derived | Zhu X, Lee ES, Chan FHF, Yin R, Lim PXH, Koh RWS, Judith C, Wei L, Li S, Phrommarad P, Chin GHY, Lim VH, Low RSY, Chen YC, Griva K. Feasibility and acceptability of a personalised self-care support programme for primary care patients with diabetic foot ulcers delivered by wound care nurses: the HEALing study protocol. BMJ Open. 2025 Oct 7;15(10):e098024. doi: 10.1136/bmjopen-2024-098024. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Study | Single-arm study: pre- and post-intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients with diabetic foot ulcers receiving wound care at the participating clinics
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Study | Single-arm study: pre- and post-intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 patients withdrew from the study due to changes to their healthcare institutions (e.g., from primary care settings to secondary/tertiary settings). | Posted | Count of Participants | Participants | 4 weeks post-intervention from baseline. |
|
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed (as this is a self-care education intervention with no risk of adverse event)
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm Study | All participants were assigned to a single intervention group receiving the programme in addition to standard diabetic foot ulcer care. No control or comparison group was included. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Wound Nurse Clinician | National Healthcare Group Polyclinics | 64966611 | julia_zhu@nhgp.com.sg |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2024 | Jun 3, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016523 | Foot Ulcer |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007871 | Leg Ulcer |
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Single-group pre-intervention and post-intervention comparison
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| 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. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Primary | Acceptability of the Intervention | Participants will be interviewed to determine the acceptability of the intervention. | Participants with diabetic foot ulcers receiving wound care at the participating primary clinics | Posted | Count of Participants | Participants | 4 weeks post-intervention from baseline. |
|
|
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| Secondary | 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. | Participants with diabetic foot ulcers receiving wound care at the participating primary care clinics (excluding 3 withdrawals due to changes to primary care institutions) | Posted | Mean | Standard Deviation | score on a scale | 4 weeks post-intervention from baseline. |
|
|
|
| Secondary | 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. | Participants with diabetic foot ulcers receiving wound care at the participating primary care clinics (excluding 3 withdrawals due to changes to primary care institutions) | Posted | Mean | Standard Deviation | score on a scale | 4 weeks post-intervention from baseline. |
|
|
|
| Secondary | 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. | Participants with diabetic foot ulcers receiving wound care at the participating primary care clinics (excluding 3 withdrawals due to changes to primary care institutions) | Posted | Mean | Standard Deviation | score on a scale | 4 weeks post-intervention from baseline. |
|
|
|
| Secondary | 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. | Participants with diabetic foot ulcers receiving wound care at the participating primary care clinics (excluding 3 withdrawals due to changes to primary care institutions) | Posted | Mean | Standard Deviation | score on a scale | 4 weeks post-intervention from baseline. |
|
|
|
| Secondary | 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. | Participants with diabetic foot ulcers receiving wound care at the participating primary care clinics (excluding 3 withdrawals due to changes to primary care institutions) | Posted | Mean | Standard Deviation | score on a scale | 4 weeks post-intervention from baseline. |
|
|
|
| Secondary | 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. | Participants with diabetic foot ulcers receiving wound care at the participating primary care clinics (excluding 3 withdrawals due to changes to primary care institutions) | Posted | Mean | Standard Deviation | score on a scale | 4 weeks post-intervention from baseline. |
|
|
|
| Secondary | 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. | Participants with diabetic foot ulcers receiving wound care at the participating primary care clinics (excluding 3 withdrawals due to changes to primary care institutions) | Posted | Mean | Standard Deviation | units on a scale | 4 weeks post-intervention from baseline. |
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| Secondary | HbA1c | HbA1c for participants who have completed the program. | Participants with an active DFU receiving wound care at the participating clinics | Posted | Mean | Standard Deviation | mmol/mol | 4 weeks post-intervention from baseline. |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D012883 |
| Skin Ulcer |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |