Adherence to Activity Limitations in Diabetes

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Foot Ulcer
• Intervention / Treatment: Behavioral: Intervention

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Derby, United Kingdom
    • Royal Derby Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patients in the control group will receive treatment as usual.
Experimental: Experimental; 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.	Behavioral: Intervention; Theory-based communication training programme delivered to healthcare professionals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Nottingham
• Investigators: Principal Investigator: Jennie Hancox, PhD, University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2019
• Primary Completion (Actual): February 14, 2020
• Study Completion (Actual): September 10, 2020

Study Registration Dates

• First Submitted: February 22, 2019
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Training; Diabetes; Adherence; Motivation; Communication; Foot Ulcer; Healthcare Professional
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Leg Ulcer; Skin Ulcer; Foot Diseases; Foot Ulcer; Ulcer
• Other Study ID Numbers: 18033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No