Condition category
Circulatory System
Date applied
10/02/2011
Date assigned
17/03/2011
Last edited
08/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.clahrc-ndl.nihr.ac.uk/our-themes/clinical-themes/stroke-rehabilitation/home-visits-after-stroke_24

Contact information

Type

Scientific

Primary contact

Dr Avril Drummond

ORCID ID

Contact details

The University of Nottingham
Division of Rehabilitation and Ageing
The Medical School
B Floor
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10031

Study information

Scientific title

A survey and feasibility randomised clinical trial (RCT) of predischarge occupational therapy home visits for stroke patients

Acronym

HOVIS

Study hypothesis

This study aims to investigate the effects of predischarge occupational therapy home visits for stroke patients. These visits are a common component of occupational therapy practice, yet relatively little research has been completed. We wish to conduct a feasibility study in order to test whether randomisation is acceptable to patients and clinicians and thus whether a multi-centre trial would be possible in order to examine the effectiveness and costs of such visits.

Ethics approval

Berkshire Research Ethics Committee 1, 17/05/2010, ref: 10/H0505/41

Study design

Single-centre single-blind feasibility randomised controlled trial

Primary study design

Interventional

Secondary study design

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

Stroke

Intervention

Predischarge home visit with an occupational therapist versus predischarge in-hospital interview with occupational therapist. Participants will be randomised to receive either a predischarge home visit or a predischarge in-hospital interview.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Independence in activities of daily living: Nottingham Extended Activities of Daily Living (NEADL) at 1 month

Secondary outcome measures

1. Mood (GHQ28 and SADQ)
2. Caregiver strain (Caregiver Strain Index)
3. Economic analysis (EQ5D)
4. Falls, hospital readmissions and use of primary and community care services at one month

Overall trial start date

12/07/2010

Overall trial end date

12/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who have had a stroke and are transferred to the stroke rehabilitation unit at the trial site

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Patients who are discharged directly from the acute stroke unit and who are not transferred for rehabilitation
2. Patients who are on an end of life care pathway
3. Patients being discharged out of the Derbyshire area
4. Patients who do not speak English
5. Patients who receive a pre-discharge occupational therapy access visit only
6. Patients who the ward clinicians decide must have a pre-discharge home visit as specified by agreed criteria will not be eligible for randomisation. However, these patients will be approached separately for consent to be followed up as ‘home visit essential’ participants

Recruitment start date

12/07/2010

Recruitment end date

12/10/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The University of Nottingham
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Collaboration for Leadership in Applied Health Research and Care - Nottinghamshire, Derbyshire and Lincolnshire (CLAHRC NDL)

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23113988

Publication citations

  1. Results

    Drummond AE, Whitehead P, Fellows K, Sprigg N, Sampson CJ, Edwards C, Lincoln NB, Occupational therapy predischarge home visits for patients with a stroke (HOVIS): results of a feasibility randomized controlled trial., Clin Rehabil, 2013, 27, 5, 387-397, doi: 10.1177/0269215512462145.

Additional files

Editorial Notes