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 measure
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 (if study stopped)
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
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
Associations and societies (private and public)
Location
United Kingdom
Funder name
Remedi (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
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
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22324056
2. 2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27645554
Publication citations
-
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.