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Completed

NCT Number: NCT03853941

Adherence to Activity Limitations in Diabetes

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.

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Key information

Conditions

Diabetes Behavior Communication Diabetes Mellitus Endocrine System Diseases Foot Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Derby Hospital

Derby, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention

Behavioral

Theory-based communication training programme delivered to healthcare professionals

Primary outcomes

  1. Change in healthcare professionals' communication style

    Time frame: 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 outcomes

  1. Change in patients' adherence to activity reduction recommendations

    Time frame: 1 month

    Measured using an accelerometer. Patients will be asked to wear the accelerometer daily for 1 month.

  2. Change in patient treatment self-regulation

    Time frame: 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.

  3. Acceptability of the intervention

    Time frame: 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.

  4. Fidelity of delivery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 26, 2019
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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