Condition category
Not Applicable
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Mark Hawley


Contact details

Health Services Research
School of Health & Related Research (ScHARR)
Regents Court
30 Regent Street
S1 4DA
United Kingdom
+44 114 222 0682

Additional identifiers

EudraCT number number

Protocol/serial number


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



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


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

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


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


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



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


Overall trial end date


Reason abandoned


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Health Services Research
S1 4DA
United Kingdom

Sponsor information


University of Sheffield (UK)

Sponsor details

Royal Hallamshire Hospital
Glossop Road
S10 2JF
United Kingdom

Sponsor type




Funder type

Research council

Funder name

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

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


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

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