Evaluation of the WISE approach in primary care: improving outcomes in chronic conditions through effective self-management

ISRCTN ISRCTN90940049
DOI https://doi.org/10.1186/ISRCTN90940049
Secondary identifying numbers 1
Submission date
20/05/2009
Registration date
03/09/2009
Last edited
16/07/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof David Thompson
Scientific

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

Email david.thompson@manchester.ac.uk

Study information

Study designTwo-arm practice-level cluster randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEvaluation 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 acronymWISE RCT
Study objectivesIs 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(s)Salford & Trafford Local Research Ethics Committee approved on the 23rd January 2009 (ref: 09/H1004/6)
Health condition(s) or problem(s) studiedChronic obstructive pulmonary disease (COPD), diabetes or irritable bowel syndrome (IBS)
InterventionThe 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 typeOther
Primary outcome measure1. 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 measures1. 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 study start date01/05/2009
Completion date01/05/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants1,728 diabetic, 1,728 COPD, and 1,728 chronic IBS patients.
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/05/2009
Date of final enrolment01/05/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Gastroenterology
Salford
M6 8HD
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

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

Email karen.shaw@manchester.ac.uk
Website http://www.manchester.ac.uk
ROR logo "ROR" https://ror.org/027m9bs27

Funders

Funder type

Government

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

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 13/05/2013 Yes No