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
Protocol serial number	1
Sponsor	University of Manchester (UK)
Funders	National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0407-10136), National Primary Care Research and Development Centre (NPCRDC) (UK)

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

Primary study design	Interventional
Study design	Two-arm practice-level cluster randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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 acronym	WISE RCT
Study objectives	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(s)	Salford & Trafford Local Research Ethics Committee approved on the 23rd January 2009 (ref: 09/H1004/6)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/05/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	5184
Key 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
Key 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
Date of first enrolment	01/05/2009
Date of final enrolment	01/05/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Gastroenterology

Salford
M6 8HD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes