Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540170
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-27
Brief Title:
A Personalized Self-care Support Program for Primary Care Patients With Diabetic Foot Ulcer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility and Acceptability of a Personalized Self-care Support Program for Primary Care Patients With Diabetic Foot Ulcer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
This study aims to assess the potential benefits 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 3-6 weeks to support emotional adjustments and DFU self-care adherence
The primary outcomes include the feasibility of recruitment and the acceptability of the proposed personalized intervention Feasibility will be assessed based on recruitment and three-month retention of participants 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 12 end of the study from enrolment to reveal any differences in PROMs and clinical outcomes Differences in PROMs between baseline and 3 months 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
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 3-6 weeks to support emotional adjustments and DFU self-care adherence
The primary outcomes include the feasibility of recruitment and the acceptability of the proposed personalized intervention Feasibility will be assessed based on recruitment and three-month retention of participants 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 12 end of the study from enrolment to reveal any differences in PROMs and clinical outcomes Differences in PROMs between baseline and 3 months 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None