CLASSIC Proactive Telephone Coaching and Tailored Support (PROTECTS)
| ISRCTN | ISRCTN12286422 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12286422 |
| Secondary identifying numbers | 16717 |
- Submission date
- 19/06/2014
- Registration date
- 19/06/2014
- Last edited
- 31/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The Salford Integrated Care Programme (SICP) is a large scale project to improve care for older people with long-term conditions and social care needs in Salford. The aim of this study is to test the effectiveness of telephone health coaching for older patients (aged 65+) with multiple long-term conditions (multi-morbidity), compared to usual care.
Who can participate?
Patients aged 65+ with two or more existing long-term conditions and assessed as needing some assistance with self-management.
What does the study involve?
Patients receive a 20-minute phone call once a month for 6 months which is delivered by experienced health advisers. The health advisers and the patient agree a plan for management of their long-term conditions, including advice on healthier diet, exercise, reduction of smoking and alcohol consumption and increased social activity, as well as support for low mood (if applicable).
What are the possible benefits and risks of participating?
Previous evidence suggests that health coaching may be effective in improving outcomes, including self-management and quality of life. However, these benefits have not been confirmed for older patients with multi-morbidity in the UK NHS. The trialists are not aware of any adverse effects from health coaching
Where is the study run from?
University of Manchester (UK)
When is the study starting and how long is it expected to run for?
July 2014 to September 2016
Who is funding the study?
NIHR Health Services and Delivery Research (UK)
Who is the main contact?
Prof. Peter Bower
Peter.Bower@manchester.ac.uk
Contact information
Scientific
5th Floor
Williamson Building
Oxford Road
Manchester
M13 9PL
United Kingdom
| Peter.Bower@manchester.ac.uk |
Study information
| Study design | Both; Interventional and Observational; Design type: Process of Care, Treatment, Cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | CLASSIC Proactive Telephone Coaching and Tailored Support (PROTECTS): a pragmatic, two-arm, patient-level, randomised trial of the effectiveness of telephone coaching and support for older people with multimorbidity |
| Study acronym | CLASSIC Proactive Telephone Coaching and Tailored Support (PROTECTS) |
| Study objectives | The Salford Integrated Care Programme (SICP) is a large scale transformational project to improve care for older people with long-term conditions and social care needs in Salford. SICP will deliver improved care through 3 core mechanisms: 1. Improved access to community resources and targeted support for self-management 2. Better integration of care through multidisciplinary health and social care groups providing structured, population based care. 3. An 'Integrated contact centre' to support navigation and self-management The Comprehensive Longitudinal Assessment of Salford Integrated Care (CLASSIC) is an evaluation framework designed to provide a rigorous test of the ability of the SICP to deliver enhanced experience of care, improved well-being and quality of life, and reduced costs of care and improved cost effectiveness. The CLASSIC evaluation framework will adopt the cohort multiple randomised controlled trial, where a large population cohort is recruited and followed over time, with subgroups of the cohort used to evaluate the outcomes of particular SICP components. An important component of the SICP is a contact centre providing ‘health coaching’. Health coaching involves ‘a regular series of phone calls between patient and health professional...to provide support and encouragement to the patient, and promote healthy behaviours such as treatment control, healthy diet, physical activity and mobility, rehabilitation, and good mental health’. |
| Ethics approval(s) | 1. First MREC approval date 29/04/2014, ref: 14/NW/0206 2. Health Coaching Sub Project (Leeds East), approval date 26/05/2015, ref: 15/YH/0129 |
| Health condition(s) or problem(s) studied | Topic: Primary Care, Ageing; Subtopic: Not Assigned, Ageing; Disease: All Diseases, All Ageing |
| Intervention | Current interventions as of 10/03/2016: The CLASSIC framework includes a large cohort of patients, which we will sample to recruit patients for a trial using the cohort multiple randomised controlled trial methodology (Relton et al 2010). The trial is called CLASSIC PROTECTS (Proactive Telephone Coaching and Tailored Support), which tests the effectiveness of telephone health coaching on the outcomes of older patients (aged 65+) with multiple long-term conditions, compared to usual care. 1306 eligible patients in the CLASSIC cohort will be randomly selected and 504 asked if they would take part in a trial of health coaching for multiple long-term conditions – a 20-minute phone call each month for 6 months. The remaining 802 will act as controls for the study, and will be followed up as part of the CLASSIC cohort. Previous interventions: The CLASSIC framework includes a large cohort of patients, which we will sample to recruit patients for a trial using the cohort multiple randomised controlled trial methodology (Relton et al 2010). The trial is called CLASSIC PROTECTS (Proactive Telephone Coaching and Tailored Support), which tests the effectiveness of telephone health coaching on the outcomes of older patients (aged 65+) with multiple long-term conditions, compared to usual care. 504 eligible patients in the CLASSIC cohort will be randomly selected and 50% (n=252) asked if they would take part in a trial of health coaching for multiple long-term conditions – a 20-minute phone call each month for 6 months. The remaining 50% will act as controls for the study, and will be followed up as part of the CLASSIC cohort. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measures as of 13/12/2016: 1. Ability to self-manage, measured using the 13-item version of the Patient Activation Measure 2. Quality of life, measured using the physical health domain of the World Health Organization Quality of Life (WHOQOL-BREF) instrument Timepoint(s): Month 0, 20 Previous primary outcome measures from 10/03/2016 to 13/12/2016: Health outcomes; Timepoint(s): Month 0, 6 Original primary outcome measures: Health outcomes; Timepoint(s): Month 0, 6, 12, 18, 24 |
| Secondary outcome measures | Current secondary outcome measures as of 13/12/2016: 1. Depression, assessed using the Mental Health Inventory-5 2. Ability to self-manage, assessed using the Summary of Diabetes Self-Care Activities (SDSCA) measure 3. Health economic analyses using the EQ5D-L measure and healthcare utilisation data Timepoint(s): Month 0, 20 Previous secondary outcome measures from 10/03/2016 to 13/12/2016: 1. Costs; Timepoint(s): Month 0, 6 2. Patient experience; Timepoint(s): Month 0, 6 Original secondary outcome measures: 1. Costs; Timepoint(s): Month 0, 6, 12, 18, 24 2. Patient experience; Timepoint(s): Month 0, 6, 12, 18, 24 |
| Overall study start date | 14/07/2014 |
| Completion date | 30/09/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned Sample Size: 504; UK Sample Size: 504; Description: Older people (65+) with long-term conditions |
| Key inclusion criteria | 1. Aged 65+ 2. 2 or more existing long-term conditions 3. Assessed as needing some assistance with self-management (defined in terms of scores on the Patient Activation Measure) |
| Key exclusion criteria | 1. Patients in the palliative care stage of condition 2. Those with conditions which reduce capacity to consent and participate |
| Date of first enrolment | 01/07/2015 |
| Date of final enrolment | 01/07/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Manchester
M13 9PL
United Kingdom
Sponsor information
University/education
c/o Ms Lynne Macrae
Oxford Road
Manchester
M13 9PL
England
United Kingdom
"ROR" |
https://ror.org/027m9bs27 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Health Services and Delivery Research (HS&DR) Programme, NIHR Health Services and Delivery Research (HS&DR) Programme, NIHR Health Services and Delivery Research Programme, HS&DR Programme, HS&DR
- Location
- United Kingdom
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 | Conferences, output listed in NIHR report |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/07/2017 | Yes | No | |
| Results article | trial within a cohort results | 30/05/2018 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| HRA research summary | 26/07/2023 | No | No |
Editorial Notes
31/05/2018: Publication reference added.
25/07/2017: Publication reference added.
