Condition category
Not Applicable
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof David Thompson


Contact details

Department of Gastroenterology
Clinical Sciences Building
Hope Hospital
Stott Lane
M6 8HD
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Evaluation of the WISE approach in primary care: improving outcomes in chronic conditions through effective self-management - a two-arm practice-level cluster randomised controlled trial



Study hypothesis

Is the adoption of the WISE approach to self management support in primary care clinically and cost-effective in the management of patients with existing long-term conditions, compared to routine primary care services?

Ethics approval

Salford & Trafford Local Research Ethics Committee approved on the 23rd January 2009 (ref: 09/H1004/6)

Study design

Two-arm practice-level cluster randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Chronic obstructive pulmonary disease (COPD), diabetes or irritable bowel syndrome (IBS)


The intervention is designed to encourage practices to adopt a structured and patient-centred approach in their routine management of long-term conditions, providing the practice with skills, resources and motivation to make changes to service delivery in line with the principles of the WISE approach. The planned approach to training combines evidence-based approaches to changing professional behaviour with approaches to 'normalise' those behaviours in current practice.

The training will seek to impart three core skills to primary care staff:
1. Assessment of the individual patient's needs in terms of their self-management capabilities and current illness trajectory
2. Shared decision making about the appropriate type of support based on that assessment (types include support from primary care, written information sources, generic support groups or condition specific education)
3. Facilitating patient access to support. This may involve signposting patients to various resources which relate to the assessment and shared decision making processes. The training will encompass ways health professionals can negotiate with and guide patients into more appropriate utilisation of health service resources. In the case of IBS, this may also involve referral to psychological treatment services (CBT and hypnotherapy) for eligible patients (so called 'stepped up care').

Training of practice staff takes place over two 3 hour sessions - the effects of the training will be determined through recording patient-level outcomes.

The control group will receive no training.

Follow-up for both arms will be at 6 months and 12 months post-intervention.

Intervention type



Not Applicable

Drug names

Primary outcome measures

1. Shared decision making
2. Self-efficacy
3. Empowerment
4. Health behaviour
5. Positive attitudes
6. Management options
7. Condition specific quality of life
8. Health related quality of life
9. Service utilisation

Measured at baseline, 6 months and 12 months.

Secondary outcome measures

1. Illness perceptions
2. Health literacy
3. Social capital
4. Shared decision making
5. Self-efficacy
6. Empowerment
7. Health behaviour
8. Positive attitudes
9. Management options
10. Condition specific quality of life

Measured at baseline, 6 months and 12 months.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Diagnosis of chronic obstructive pulmonary disease (COPD), diabetes or irritable bowel syndrome (IBS) (identified from the GP systems using appropriate Read codes and verified by the GP)
2. Sufficient English to be able to complete questionnaires
3. Agreement from the practice that the patient is appropriate for research assessment
4. Aged greater than or equal to 18 years, either sex

Participant type


Age group




Target number of participants

1,728 diabetic, 1,728 COPD, and 1,728 chronic IBS patients.

Participant exclusion criteria

1. In the palliative care stage of condition
2. Receiving management primarily from a specialist nurse rather than a practice nurse or GP
3. Mental health problems such as those which reduce capacity to consent and participate

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Department of Gastroenterology
M6 8HD
United Kingdom

Sponsor information


University of Manchester (UK)

Sponsor details

R&D office 2nd Floor Christie Build
University of Manchester
Oxford Road
M13 9PL
United Kingdom

Sponsor type




Funder type


Funder name

National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0407-10136)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

National Primary Care Research and Development Centre (NPCRDC) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in

Publication citations

  1. Results

    Kennedy A, Bower P, Reeves D, Blakeman T, Bowen R, Chew-Graham C, Eden M, Fullwood C, Gaffney H, Gardner C, Lee V, Morris R, Protheroe J, Richardson G, Sanders C, Swallow A, Thompson D, Rogers A, , Implementation of self management support for long term conditions in routine primary care settings: cluster randomised controlled trial., BMJ, 2013, 346, f2882.

Additional files

Editorial Notes