Contact information
Type
Scientific
Primary contact
Prof David Thompson
ORCID ID
Contact details
Department of Gastroenterology
Clinical Sciences Building
Hope Hospital
Stott Lane
Salford
M6 8HD
United Kingdom
david.thompson@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
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
Acronym
WISE RCT
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
Interventional
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
Condition
Chronic obstructive pulmonary disease (COPD), diabetes or irritable bowel syndrome (IBS)
Intervention
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
Other
Phase
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
01/05/2009
Overall trial end date
01/05/2011
Reason abandoned
Eligibility
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
Patient
Age group
Adult
Gender
Both
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
01/05/2009
Recruitment end date
01/05/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Gastroenterology
Salford
M6 8HD
United Kingdom
Sponsor information
Organisation
University of Manchester (UK)
Sponsor details
R&D office 2nd Floor Christie Build
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
karen.shaw@manchester.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
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
Location
Funder name
National Primary Care Research and Development Centre (NPCRDC) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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 http://www.ncbi.nlm.nih.gov/pubmed/23670660
Publication citations
-
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.