Condition category
Nervous System Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
18/09/2012
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 N Lincoln

ORCID ID

Contact details

University of Nottingham
University Hospital
Institute of work
Health and Organisations
8 William Lee buildings
Science and Technology Park
University Boulevard
Nottingham
NG7 2RQ
United Kingdom
+44 (0)115 87523846
nadina.lincoln@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0192147133

Study information

Scientific title

A comparison of the effectiveness of two types of neuropsychological rehabilitation for memory deficits following brain damage: A single blind randomised controlled trial

Acronym

ReMIND - Pilot study

Study hypothesis

The aim of this study is to compare the effectiveness of two types of cognitive rehabilitation techniques (ie restitution and compensation) in reducing memory deficits following brain damage.

Ethics approval

Ethical approval obtained from Central Office for Research Ethics Committees, Nottingham Research Ethics Committee 1 (12 May 2004)

Study design

Single blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

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

Condition

Stroke, Traumatic Brain Injury (TBI), Multiple Sclerosis (MS) / memory deficits

Intervention

1. Restitution group
2. Compensation group
3. Attention placebo group

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Prior to July 2008:
To assess memory functions, disability, psychological adjustment.

Modified July 2008:
To assess everyday memory functions, based on the Everyday Memory Questionnaire.

Secondary outcome measures

Added July 2008:
Objective measures of memory (RBMTE, Doors & People, Memory Aids Questionnaire), mood (GHQ12, Wimbledon Self Report Scale), psychological adjustment (Mental Adjustment to Brain Damage), and extended activities of daily living (Nottingham EADL).

Overall trial start date

24/05/2004

Overall trial end date

31/01/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Prior to July 2008:
Participants having sustained a brain damage, verified by hospital or GP records, should have a memory deficit, defined as overall profile score of 1 (poor memory) or 0 (impaired) on the Rivermead Behavioural memory Test (RBMT), over 18 years of age, living in or around Nottingham (within 50 miles radius), having at least one identified individual who will supervise homework assignments, they give informed consent, they are not blind or deaf, should speak English, should have been diagnosed at least one month prior to recruitment to the study, should be more than one month post injury and or diagnosis, no previous diagnosis of brain damage or other severe disability.

Modified July 2008:
Participants with a stroke, TBI, or MS, verified by hospital or GP records, should have a memory deficit, defined as overall profile score of 2 (average memory) to 0 (impaired) on the Rivermead Behavioural memory Test-extended version (RBMTE), over 18 years of age, living in or around Nottingham or Derby (within 50 miles radius), having at least one identified individual who will supervise homework assignments, they give informed consent, should speak English, and should be more than one month post injury and or diagnosis.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

At least 60 patients in each group (restitution group, compensation group, attention placebo group) = 180.

Participant exclusion criteria

Added July 2008:
Those who are blind or deaf, have previous diagnosis of brain damage or dementia, have severe activity limitations which would restrict them from taking part in assessments or intervention, current psychiatric/mental health problems, and language problems (defined as a score of less than 15 on the Sheffield Screening Test for Acquired Language Disorders).

Recruitment start date

24/05/2004

Recruitment end date

31/01/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Nottingham
Nottingham
NG7 2RQ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Queen's Medical Centre University Hospital NHS Trust (UK) NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Added July 2008:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Stroke Association (UK) (AHP Research Bursary)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Funder name

Remedi (UK)

Alternative name(s)

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22324056

Publication citations

  1. Results

    das Nair R, Lincoln NB, Evaluation of rehabilitation of memory in neurological disabilities (ReMiND): a randomized controlled trial., Clin Rehabil, 2012, 26, 10, 894-903, doi: 10.1177/0269215511435424.

Additional files

Editorial Notes