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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03360058
Other study ID # GN17DI319
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 7, 2017
Est. completion date November 1, 2018

Study information

Verified date November 2018
Source NHS Greater Glasgow and Clyde
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To ensure that patients who are overweight or obese and have type 2 diabetes are identified, receive personalised diabetes care, have the issue of weight raised and explained in a non-judgemental manner by staff in primary care, and are referred on to weight management services as appropriate ensuring equity of access across NHS Greater Glasgow and Clyde.

Specific aims of the whole project:

1. To improve GP/ primary care staff knowledge of the evidence base for the management of diabetes when there is co-existing obesity and local care pathways

2. To increase GP/ primary care staff knowledge of and confidence in their role in raising the issue of weight management,

3. To improve primary care referral rates of appropriate patients who are overweight or obese and have type 2 diabetes, and are "ready to change" to NHS funded weight management services

4. To improve patient uptake of and attendance at NHS funded weight management services NB This is a service evaluation of a training programme being delivered by NHS Greater Glasgow and Clyde Health Improvement. Full ethical approvals are being sought due to the randomised design and so that results can be generalised and published.


Description:

The Glasgow and Clyde weight management service (GCWMS) delivers a specialist multi-disciplinary, multi-component weight management programme throughout the Glasgow and Clyde area. In a recent evaluation of the service, the authors highlighted that 27% of the patients who are referred to the programme do not opt into the service. This describes patients who are referred via their GP practice and do not contact the service to opt into an initial assessment.

Similarly, Brook et al described initial uptake and engagement of a small weight management programme of 502 patients. In addition to completing an extensive questionnaire, patients were requested to call to make an appointment with the service personally. Of those referred to the programme, 46% did not opt in.

Engaging patients in a weight management programme is especially difficult, even when the intervention is provided via the primary care route. For example, The Counterweight Project, a weight management programme delivered via the GP surgery, has been taken up by a number of surgeries in Scotland, however after 2 years, one fifth of enlisted practices failed to enrol patients onto the programme.

Even when GP's do address matters of weight related behaviour, there is often disagreement from the patient that the topic has been raised. In a sample of 456 patients, 39% of patients disagreed with GP reporting about the content of the discussion during consultations regarding weight, diet and physical activity. In particular, GP's reported more occasions of discussing weight than patients in 12.5% of consultations. Patients' likeliness to engage in a weight management programme is also influenced by practice endorsement and opinion of the GP of the intervention available in addition to other factors: clear understanding of the programme, clear understanding of the programme goals, structured pro-active follow-up and perception of positive outcomes.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date November 1, 2018
Est. primary completion date November 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- GP practices in NHS Greater Glasgow and Clyde which:

- Have a contract for local enhanced services for long term conditions (Diabetes)

- Have a unique clinical database (i.e. not shared with another practice)

Exclusion Criteria:

- "17c" practices (those with a separate contract for long term conditions)

- Those practices with a database shared with another practice (8 practices in area)

Study Design


Intervention

Behavioral:
Small Talk Big Difference Immediate access training
Immediate access to 1 hour online training and supporting print materials for implementation in primary care practice
Small Talk Big Difference delayed access training
Delayed access (by 4 months) to 1 hour online training and supporting print materials for implementation in primary care practice

Locations

Country Name City State
United Kingdom Glasgow Cardiovascular Research Centre Glasgow Scotland

Sponsors (2)

Lead Sponsor Collaborator
NHS Greater Glasgow and Clyde University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measure the effectiveness of an online training programme, practice implementation toolkit and face to face training for primary care staff which will be measured as number of patient referrals and patient attendance at NHS funded weight management services 12 months
Secondary Implementation/ Normalization NOMAD questionnaire will be used to ascertain how STBD impacts on primary care clinicians work 12 months
Secondary Percentage of diabetes reviews with recorded weight management discussion in LES template percentage of diabetes review in primary care 12 months
Secondary Training uptake Training uptake - online, face to face and experiential
By practice
By GP and practice Nurse By diabetes lead
12 months
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