Condition category
Not Applicable
Date applied
18/06/2010
Date assigned
18/06/2010
Last edited
01/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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
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 controlled trial

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

http://www.sheffield.ac.uk/

Funders

Funder type

Research council

Funder name

Engineering and Physical Sciences Research Council (EPSRC) (UK)

Alternative name(s)

EPSRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Publication citations

Additional files

Editorial Notes