Exploratory trial of the WISE approach in primary care
| ISRCTN | ISRCTN87042862 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87042862 |
| Protocol serial number | 4407 |
| Sponsor | University of Manchester (UK) |
| Funder | National Primary Care Research and Development Centre (NPCRDC) (UK) (ref: R01135) |
- Submission date
- 29/04/2010
- Registration date
- 29/04/2010
- Last edited
- 25/07/2013
- 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
Miss Anne Kennedy
Scientific
Scientific
Oxford Road
Manchester
M13 9PL
United Kingdom
Study information
| Primary study design | Observational |
|---|---|
| Study design | Non-randomised interventional and observational process of care qualitative study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Improving outcomes in chronic conditions through effective self-management: exploratory trial of the WISE model in primary care |
| Study acronym | WISE |
| Study objectives | To test and refine a self care support training intervention for primary care. |
| Ethics approval(s) | Oldham LREC approved on the 15th January 2008 (ref: 07/H1011/96) |
| Health condition(s) or problem(s) studied | Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases |
| Intervention | Two practices to take part in the training. The impact of the training to be assessed by: 1. Observations during the training sessions 2. Interviews following the training with clinicians and administrative staff 3. Four pre- and four post-training recordings of consultations per clinician 4. Qualitative interviews with patients: 4.1. 20 'think aloud' interviews to explore how patients use a new assessment tool developed for the WISE approach 4.2. 25 in depth interviews with patients exploring issues related to self care Study entry: registration only |
| Intervention type | Other |
| Primary outcome measure(s) |
Training is robust and effective for routine delivery in primary care |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 173 |
| Key inclusion criteria | 1. Diagnosis of diabetes, chronic obstructive pulmonary disease (COPD) or irritable bowel syndrome (IBS) 2. Either sex, no age limit |
| Key exclusion criteria | 1. Patients in the palliative care stage of condition 2. Those receiving management from a specialist nurse rather than primarily practice nurse or GP 3. Mental health problems such as those which reduce capacity to consent and participate |
| Date of first enrolment | 01/05/2008 |
| Date of final enrolment | 31/03/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Oxford Road
Manchester
M13 9PL
United Kingdom
M13 9PL
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 | 29/01/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
