Condition category
Not Applicable
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
25/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Anne Kennedy

ORCID ID

Contact details

Oxford Road
Manchester
M13 9PL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4407

Study information

Scientific title

Improving outcomes in chronic conditions through effective self-management: exploratory trial of the WISE model in primary care

Acronym

WISE

Study hypothesis

To test and refine a self care support training intervention for primary care.

Ethics approval

Oldham LREC approved on the 15th January 2008 (ref: 07/H1011/96)

Study design

Non-randomised interventional and observational process of care qualitative study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

GP practices

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase II

Drug names

Primary outcome measures

Training is robust and effective for routine delivery in primary care

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/05/2008

Overall trial end date

31/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of diabetes, chronic obstructive pulmonary disease (COPD) or irritable bowel syndrome (IBS)
2. Either sex, no age limit

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

Planned Sample Size: 173; UK Sample Size: 173

Participant 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

Recruitment start date

01/05/2008

Recruitment end date

31/03/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Research and Development office
2nd Floor Christie Building
Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

http://www.manchester.ac.uk/

Funders

Funder type

Government

Funder name

National Primary Care Research and Development Centre (NPCRDC) (UK) (ref: R01135)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20181050

Publication citations

  1. Results

    Kennedy A, Chew-Graham C, Blakeman T, Bowen A, Gardner C, Protheroe J, Rogers A, Gask L, Delivering the WISE (Whole Systems Informing Self-Management Engagement) training package in primary care: learning from formative evaluation., Implement Sci, 2010, 5, 7, doi: 10.1186/1748-5908-5-7.

Additional files

Editorial Notes