Adherence to Activity Limitations in Diabetes

University of Nottingham

Status: Completed

Conditions: Diabetes; Foot Ulcer

Treatments: Behavioral: Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03853941

18033

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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49 participants in 2 patient groups

Control

No Intervention group

Description:

Patients in the control group will receive treatment as usual.

Experimental

Experimental group

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.

Treatment:

Behavioral: Intervention