Contact information
Type
Scientific
Primary contact
Prof Mark Hawley
ORCID ID
Contact details
Health Services Research
School of Health & Related Research (ScHARR)
Regents Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
+44 114 222 0682
mark.hawley@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4912
Study information
Scientific title
Multicentre non-randomised interventional process of care trial of self-management of chronic conditions supported by assistive, rehabilitation and telecare technology
Acronym
SMART 2
Study hypothesis
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
Leeds East REC, 03/06/2008, ref: 08/H1306/46
Study design
Multicentre non-randomised interventional process of care trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
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: 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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/01/2008
Overall trial end date
31/12/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
Planned sample size: 150
Participant 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
Recruitment start date
01/01/2008
Recruitment end date
31/12/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Health Services Research
Sheffield
S1 4DA
United Kingdom
Sponsor information
Organisation
University of Sheffield (UK)
Sponsor details
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Engineering and Physical Sciences Research Council (EPSRC) (UK)
Alternative name(s)
EPSRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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