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
Scientific
Department of Gastroenterology
Clinical Sciences Building
Hope Hospital
Stott Lane
Salford
M6 8HD
United Kingdom
| david.thompson@manchester.ac.uk |
Study information
| Study design | Two-arm practice-level cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/05/2009 |
| Completion date | 01/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1,728 diabetic, 1,728 COPD, and 1,728 chronic IBS patients. |
| 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
- England
- United Kingdom
Study participating centre
Department of Gastroenterology
Salford
M6 8HD
United Kingdom
M6 8HD
United Kingdom
Sponsor information
University of Manchester (UK)
University/education
University/education
R&D office 2nd Floor Christie Build
University of Manchester
Oxford Road
Manchester
M13 9PL
England
United Kingdom
| karen.shaw@manchester.ac.uk | |
| Website | http://www.manchester.ac.uk |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
