Adherence to Activity Limitations in Diabetes

NCT ID: NCT03853941

Last Updated: 2022-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-21

Study Completion Date

2020-09-10

Brief Summary

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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

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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.

Conditions

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Diabetes Foot Ulcer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

Patients in the control group will receive treatment as usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Intervention

Intervention Type BEHAVIORAL

Theory-based communication training programme delivered to healthcare professionals

Interventions

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Intervention

Theory-based communication training programme delivered to healthcare professionals

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennie Hancox, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

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Royal Derby Hospital

Derby, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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18033

Identifier Type: -

Identifier Source: org_study_id

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