Condition category
Circulatory System
Date applied
13/02/2006
Date assigned
18/04/2006
Last edited
03/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.healthsci.bham.ac.uk/physioOccupationalTherapyResearch/index.htm

Contact information

Type

Scientific

Primary contact

Prof Catherine Sackley

ORCID ID

Contact details

School of Health Sciences
52 Pritchatt's Road
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 4198
c.m.sackley@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

554/1474

Study information

Scientific title

Acronym

RICH-T

Study hypothesis

Does a rehabilitation intervention targeting mobility and self-care independence reduce deterioration in independence and immobility-related complications?

Ethics approval

The Applied and Qualitative Research Ethics Committee, Oxfordshire National Health Service (NHS) gave ethical approval for the study on 04/02/2003. Site-specific assessment approval was also granted in both the South and East Birmingham Local Research Ethics Committees, reference number: A02.072 REC 2003/247L

Study design

Cluster, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Stroke and other vascular diseases

Intervention

An evidence-based occupational therapy and physiotherapy intervention, including individual treatments, group treatments and staff education versus usual care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Independence and mobility measured by the Barthel ADL Index and the Rivermead mobility index

Secondary outcome measures

1. Emotional distress - hospital anxiety and depression scale or the stroke aphasia depression scale (if unable to communicate verbally or in writing)
2. Mobility - timed up and go
3. Bone density - lunar achilles express ultrasonometer
4. Strength - hand grip dynamometer
5. Health economics - EuroQol
6. Complication events such as pressure sores, falls and fear of falling were also recorded

Overall trial start date

01/05/2004

Overall trial end date

31/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Reduced self-care independence, as indicated by a Barthel activities of daily living (ADL) index score between 5 and 15 inclusively

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

250

Participant exclusion criteria

End of life stage of illness (e.g. life expectancy <1 year)

Recruitment start date

01/05/2004

Recruitment end date

31/05/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Health Sciences
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

c/o Brian Berry
Research Enterprise Services
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

The Health Foundation (UK) - reference number 554/1474

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19723707

Publication citations

  1. Results

    Sackley CM, van den Berg ME, Lett K, Patel S, Hollands K, Wright CC, Hoppitt TJ, Effects of a physiotherapy and occupational therapy intervention on mobility and activity in care home residents: a cluster randomised controlled trial., BMJ, 2009, 339, b3123.

Additional files

Editorial Notes