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ISRCTN
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ISRCTN31254396
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ClinicalTrials.gov identifier
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Public title
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Self Management supported by Assistive, Rehabilitation and Telecare Technologies
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Scientific title
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Multicentre non-randomised interventional process of care trial of self-management of chronic conditions supported by assistive, rehabilitation and telecare technology
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Acronym
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SMART 2
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Serial number at source
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4912
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Leeds East REC approved on the 3rd June 2008 (ref: 08/H1306/46)
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Study design
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Multicentre non-randomised interventional process of care trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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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
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Participants - inclusion criteria
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User participants with one of the following conditions:
1. Stroke, congestive heart failure (CHF) and chronic pain
2. People with stroke - up to two 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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/2008
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Anticipated end date
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31/12/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned sample size: 150
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Interventions
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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.
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Primary outcome measure(s)
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To investigate how technology can be used to construct tailored plans of interventions to be undertaken
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Secondary outcome measure(s)
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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
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Sources of funding
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Engineering and Physical Sciences Research Council (EPSRC) (UK)
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Trial website
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Publications
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Contact name
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Prof
Mark
Hawley
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Address
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Health Services Research
School of Health & Related Research (ScHARR)
Regents Court
30 Regent Street
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City/town
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Sheffield
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Zip/Postcode
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S1 4DA
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Country
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United Kingdom
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Email
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mark.hawley@sheffield.ac.uk
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Sponsor
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University of Sheffield (UK)
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Address
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Royal Hallamshire Hospital
Glossop Road
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City/town
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Sheffield
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Zip/Postcode
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S10 2JF
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Country
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United Kingdom
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Sponsor website:
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http://www.sheffield.ac.uk/
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Date applied
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18/06/2010
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Last edited
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12/11/2010
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Date ISRCTN assigned
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18/06/2010
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