Self-management supported by assistive, rehabilitation and telecare technologies

ISRCTN	ISRCTN31254396
DOI	https://doi.org/10.1186/ISRCTN31254396
Secondary identifying numbers	4912

Submission date: 18/06/2010
Registration date: 18/06/2010
Last edited: 11/05/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Mark Hawley
Scientific

Health Services Research
School of Health & Related Research (ScHARR)
Regents Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom

Phone	+44 114 222 0682
Email	mark.hawley@sheffield.ac.uk

Study information

Study design	Multicentre non-randomised interventional process of care trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Multicentre non-randomised interventional process of care trial of self-management of chronic conditions supported by assistive, rehabilitation and telecare technology
Study acronym	SMART 2
Study objectives	The overall aim of this project is to deepen understanding of the potential for technology support of self management. The use of technology for this purpose is now attracting attention, but there are some fundamental issues that need to be researched. These include how information on changes in chronic conditions can be collated and fed back to users in a meaningful and usable way to help them to understand their condition; how such information, remote from a clinician, can be presented to promote behaviour change and how this information can allow people to adjust life goals to accommodate and aid acceptance of their condition.
Ethics approval(s)	Leeds East REC, 03/06/2008, ref: 08/H1306/46
Health condition(s) or problem(s) studied	Topic: Generic Health Relevance and Cross Cutting Themes, Primary Care Research Network for England; Subtopic: Not Assigned, Generic Health Relevance (all Subtopics); Disease: All Diseases, Other
Intervention	A series of focus groups will be carried out during the first 3 - 6 months of the study. Home visits with up to five volunteer participants will take place after these focus groups (months 4 - 7). In year 2 and 3 we will undertake evaluation sessions at approximately 6-monthly intervals when elements of the PSMS will be delivered to the clinical research teams by technologists working at the University of Ulster. A series of focus groups exclusively for clinicians specialising in treatment and rehabilitation of each of the three conditions will be conducted from month 6 onwards.
Intervention type	Other
Primary outcome measure	To investigate how technology can be used to construct tailored plans of interventions to be undertaken
Secondary outcome measures	1. To examine the extent to which behaviour change is promoted through personalised feedback 2. To identify how information on signs, symptoms and lifestyle consequences can be fed back to users in a usable way 3. To identify how relevant signs, symptoms and lifestyle consequences of long-term conditions can be effectively monitored and modelled
Overall study start date	01/01/2008
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	Planned sample size: 150
Key inclusion criteria	User participants with one of the following conditions: 1. Stroke, congestive heart failure (CHF) and chronic pain 2. People with stroke - up to 2 years post stroke 3. People diagnosed with chronic heart failure (CHF) (New York Heart Association [NYHA]) 2, 3 or 4 4. Living in the community 5. Access to a telephone line 6. Sufficient English language skills in order to understand and express themselves verbally Carer participants: 7. Co-resident with patient participant or in very frequent contact with them Clinician participants: 8. Currently involved in delivery of services to people with one of the three conditions
Key exclusion criteria	User participants: 1. Co-morbid cognitive or physical impairment to the extent that it will hinder participants from giving informed consent and/or talking in a group setting 2. In-patient in a hospital or other residential setting Carer participants: 3. Not having a large amount of contact with a patient who has agreed to participate in the study
Date of first enrolment	01/01/2008
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Health Services Research

Sheffield
S1 4DA
United Kingdom

Sponsor information

University of Sheffield (UK)
University/education

Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
England
United Kingdom

Website	http://www.sheffield.ac.uk/
"ROR"	https://ror.org/05krs5044

Funders

Funder type

Research council

Engineering and Physical Sciences Research Council (EPSRC) (UK)
Government organisation / National government

Alternative name(s): UKRI Engineering and Physical Sciences Research Council, Engineering and Physical Sciences Research Council - UKRI, Engineering & Physical Sciences Research Council, EPSRC
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	Not provided at time of registration
IPD sharing plan

Editorial Notes

11/05/2017: No publications found in PubMed, verifying study status with principal investigator