Support Centre
24 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

New application
Updating record

governing board
data set
letter of agreement
request information
guidance notes

[ Print-friendly version ]
Evaluation of the WISE approach in primary care: improving outcomes in chronic conditions through effective self-management
DOI 10.1186/ISRCTN90940049
ClinicalTrials.gov identifier
EudraCT number
Public title Evaluation of the WISE approach in primary care: improving outcomes in chronic conditions through effective self-management
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
Serial number at source 1
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?
Lay summary Not provided at time of registration
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
Countries of recruitment United Kingdom
Disease/condition/study domain Chronic obstructive pulmonary disease (COPD), diabetes or irritable bowel syndrome (IBS)
Participants - 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
Participants - 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
Anticipated start date 01/05/2009
Anticipated end date 01/05/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 1,728 diabetic, 1,728 COPD, and 1,728 chronic IBS patients.
Interventions 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.
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.
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.
Sources of funding 1. National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0407-10136)
2. National Primary Care Research and Development Centre (NPCRDC) (UK)
Trial website
Publications 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23670660
Contact name Prof  David  Thompson
  Address Department of Gastroenterology
Clinical Sciences Building
Hope Hospital
Stott Lane
  City/town Salford
  Zip/Postcode M6 8HD
  Country United Kingdom
  Email david.thompson@manchester.ac.uk
Sponsor University of Manchester (UK)
  Address R&D office 2nd Floor Christie Build
University of Manchester
Oxford Road
  City/town Manchester
  Zip/Postcode M13 9PL
  Country United Kingdom
  Email karen.shaw@manchester.ac.uk
  Sponsor website: http://www.manchester.ac.uk
Date applied 20/05/2009
Last edited 16/07/2013
Date ISRCTN assigned 03/09/2009
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.