DiabetesNCT03853941
Adherence to Activity Limitations in Diabetes
A study testing Intervention in people with Diabetes and Foot Ulcer, run by University of Nottingham at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Foot Ulcer
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Mar 2019to 10 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes, Foot Ulcer
- Being tested
- Intervention
- Keywords
- Motivation, Communication, Healthcare Professional, Training, Adherence, Diabetes, Foot Ulcer
- Medical subject headings
- Diabetes Mellitus, Foot Ulcer, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Theory-based communication training programme delivered to healthcare professionals
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (4)
Change in patients' adherence to activity reduction recommendations
Measured using an accelerometer. Patients will be asked to wear the accelerometer daily for 1 month.
Measured: 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.
Measured: Baseline
Acceptability of the intervention
Assessed via interviews with healthcare professionals who have taken part in the training programme and patients.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start21 Mar 2019
- Primary completion14 Feb 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennie Hancox, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853941
- Sponsor's protocol ID
- 18033
- Status last verified
- May 2022
- First submitted
- 22 Feb 2019
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Activity Limitation Recommendations in Patients With Diabetic Foot Ulcers: a 'Proof of Concept' Study
- ClinicalTrials.gov ID
- NCT03853941
- Acronym / sponsor ID
- 18033
- Conditions
- Diabetes, Foot Ulcer
- Keywords
- Motivation, Communication, Healthcare Professional, Training, Adherence, Diabetes, Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients in the control group will receive treatment as usual. |
| Experimental | Experimental | Behavioral: InterventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionTheory-based communication training programme delivered to healthcare professionals | Behavioural | Experimental |
Primary outcome
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.
4 secondary outcomes
Change in patients' adherence to activity reduction recommendations
Time frame: 1 month
Change in patient treatment self-regulation
Time frame: Baseline
Acceptability of the intervention
Time frame: Healthcare professional interviews 4-6 weeks following training; Patient interviews 4-6 weeks following baseline
Fidelity of delivery
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennie Hancox, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Diabetes and Foot Ulcer, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in healthcare professionals' communication style (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022; AzTrials last refreshed its copy on 29 Oct 2026.