Adherence to Activity Limitations in Diabetes

Diabetes Clinical Trial

Official title:

Adherence to Activity Limitation Recommendations in Patients With Diabetic Foot Ulcers: a 'Proof of Concept' Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03853941
• Other study ID #: 18033
• Status: Completed
• Phase: N/A
• Start date: March 21, 2019
• Est. completion date: September 10, 2020

Study information

• Verified date: May 2022
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to develop and test a theory-based motivation communication training programme for healthcare professionals working with diabetic foot ulcer patients. The investigators will explore the acceptability of the training programme and examine whether the training leads to changes in healthcare professionals' communication style, and results in greater adherence to treatment recommendations (i.e., reduced weight-bearing) in patients.

Description:

This is a proof of concept, two-arm non-randomised, controlled before-and-after study. Patient outcomes (perceptions of healthcare professional communication style, treatment self-regulation and adherence to activity reduction) will be collected first during a control/usual care period. Healthcare professionals will then receive the theory-based motivation communication training programme. Subsequently a new group of patients will be recruited as the intervention group and the same outcome measures collected. Control group outcomes will be compared to intervention group outcomes. Interviews will be conducted with healthcare professionals and patients to assess acceptability of the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 10, 2020
• Est. primary completion date: February 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be aged 18 years and over
• Have diabetes according to WHO criteria
• Have a diabetic foot ulcer being treated at the foot clinic at Royal Derby Hospital
• Be able to communicate and complete questionnaire measures in English
• Have capacity to consent and agree to participate.

Exclusion Criteria:

• Patients who are not currently engaging in walking behaviour (e.g., wheelchair-bound patients) or have other physical limitations that restrict ability to use an accelerometer will be excluded.

Related Conditions & MeSH terms

• Diabetes
• Foot Ulcer
• Ulcer

Intervention

Behavioral:
• Intervention
Theory-based communication training programme delivered to healthcare professionals

Locations

Country	Name	City	State
United Kingdom	Royal Derby Hospital	Derby

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in healthcare professionals' communication style	Measured using the 6-item Health Care Climate Questionnaire, and indicated by patients' perceptions of healthcare professional autonomy support being higher in the intervention group compared to the control group.	Baseline
Secondary	Change in patients' adherence to activity reduction recommendations	Measured using an accelerometer. Patients will be asked to wear the accelerometer daily for 1 month.	1 month
Secondary	Change in patient treatment self-regulation	Treatment self-regulation is the reasons why patients may adhere or not and is a potential mechanism explaining the relationship between healthcare professional autonomy support and patient adherence to treatment recommendations.	Baseline
Secondary	Acceptability of the intervention	Assessed via interviews with healthcare professionals who have taken part in the training programme and patients.	Healthcare professional interviews 4-6 weeks following training; Patient interviews 4-6 weeks following baseline
Secondary	Fidelity of delivery	A researcher will sit in on up to 20 patient/healthcare professional consultation sessions (10 prior to training and 10 post training). The researcher will record observations of the communication style used by the healthcare professionals within the sessions. Observations will be assessed for fidelity of delivery using a checklist developed specifically for this study. Data from pre and post-training observations will be compared for differences in communication style.	Baseline