Adherence to Activity Limitations in Diabetes

Not Applicable

Completed

• Conditions: Diabetes; Foot Ulcer
• Interventions: Behavioral: Intervention

• Registration Number: NCT03853941
• Lead Sponsor: University of Nottingham

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-02-22
• Study First Submitted QC: 2019-02-22
• Study First Posted: 2019-02-26
• Study Start: 2019-03-21
• Primary Completion: 2020-02-14
• Study Completion: 2020-09-10
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-20
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Experimental	Intervention	The experimental group will receive clinical treatment as usual, however, the healthcare professionals treating them will have received training on how to enhance patient adherence via the use of a motivationally supportive communication style. Thus, the style/language healthcare professionals use to convey usual treatment recommendations may differ.

Primary Outcome Measures

Name	Time	Method
Change in healthcare professionals' communication style	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Change in patients' adherence to activity reduction recommendations	1 month	Measured using an accelerometer. Patients will be asked to wear the accelerometer daily for 1 month.
Acceptability of the intervention	Healthcare professional interviews 4-6 weeks following training; Patient interviews 4-6 weeks following baseline	Assessed via interviews with healthcare professionals who have taken part in the training programme and patients.
Change in patient treatment self-regulation	Baseline	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.
Fidelity of delivery	Baseline	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.

Trial Locations

Locations (1)

Royal Derby Hospital; 🇬🇧 Derby, United Kingdom