Condition category
Not Applicable
Date applied
19/06/2014
Date assigned
19/06/2014
Last edited
10/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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 will 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 will 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. We 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

Trial website

Under construction

Contact information

Type

Scientific

Primary contact

Prof Peter Bower

ORCID ID

Contact details

5th Floor
Williamson Building
Oxford Road
Manchester
M13 9PL
United Kingdom
-
Peter.Bower@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16717

Study information

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

Acronym

CLASSIC Proactive Telephone Coaching and Tailored Support (PROTECTS)

Study hypothesis

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

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

Study design

Both; Interventional and Observational; Design type: Process of Care, Treatment, Cohort study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Condition

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

Phase

Drug names

Primary outcome measures

Current primary outcome measures as of 10/03/2016:
Health outcomes; Timepoint(s): Month 0, 6

Previous primary outcome measures:
Health outcomes; Timepoint(s): Month 0, 6, 12, 18, 24

Secondary outcome measures

Current secondary outcome measures as of 10/03/2016:
1. Costs; Timepoint(s): Month 0, 6
2. Patient experience; Timepoint(s): Month 0, 6

Previous 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 trial start date

14/07/2014

Overall trial end date

30/09/2016

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned Sample Size: 504; UK Sample Size: 504; Description: Older people (65+) with long-term conditions

Participant exclusion criteria

1. Patients in the palliative care stage of condition
2. Those with conditions which reduce capacity to consent and participate.

Recruitment start date

01/07/2015

Recruitment end date

01/07/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Manchester
5th Floor, Williamson Building
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

c/o Ms Lynne Macrae
Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Health Services and Delivery Research; Grant Codes: 12/130/33

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Conferences, output listed in NIHR report

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes