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Adherence to Activity Limitations in Diabetes

Primary Purpose

Diabetes, Foot Ulcer

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intervention
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes focused on measuring Motivation, Communication, Healthcare Professional, Training, Adherence, Diabetes, Foot Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Derby Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Experimental

Arm Description

Patients in the control group will receive treatment as usual.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in patients' adherence to activity reduction recommendations
Measured using an accelerometer. Patients will be asked to wear the accelerometer daily for 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.
Acceptability of the intervention
Assessed via interviews with healthcare professionals who have taken part in the training programme and patients.
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.

Full Information

First Posted
February 22, 2019
Last Updated
May 20, 2022
Sponsor
University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT03853941
Brief Title
Adherence to Activity Limitations in Diabetes
Official Title
Adherence to Activity Limitation Recommendations in Patients With Diabetic Foot Ulcers: a 'Proof of Concept' Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 21, 2019 (Actual)
Primary Completion Date
February 14, 2020 (Actual)
Study Completion Date
September 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Foot Ulcer
Keywords
Motivation, Communication, Healthcare Professional, Training, Adherence, Diabetes, Foot Ulcer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in the control group will receive treatment as usual.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
Theory-based communication training programme delivered to healthcare professionals
Primary Outcome Measure Information:
Title
Change in healthcare professionals' communication style
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Change in patients' adherence to activity reduction recommendations
Description
Measured using an accelerometer. Patients will be asked to wear the accelerometer daily for 1 month.
Time Frame
1 month
Title
Change in patient treatment self-regulation
Description
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.
Time Frame
Baseline
Title
Acceptability of the intervention
Description
Assessed via interviews with healthcare professionals who have taken part in the training programme and patients.
Time Frame
Healthcare professional interviews 4-6 weeks following training; Patient interviews 4-6 weeks following baseline
Title
Fidelity of delivery
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennie Hancox, PhD
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Derby Hospital
City
Derby
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Adherence to Activity Limitations in Diabetes

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