Rehabilitation of Memory in Neurological Disabilities - Pilot study

ISRCTN	ISRCTN92582254
DOI	https://doi.org/10.1186/ISRCTN92582254
Secondary identifying numbers	N0192147133

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 21/02/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof N Lincoln
Scientific

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

Phone	+44 (0)115 87523846
Email	nadina.lincoln@nottingham.ac.uk

Study information

Study design	Single blind randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	ReMIND - Pilot study
Study objectives	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(s)	Ethical approval obtained from Central Office for Research Ethics Committees, Nottingham Research Ethics Committee 1 (12 May 2004)
Health condition(s) or problem(s) studied	Stroke, Traumatic Brain Injury (TBI), Multiple Sclerosis (MS) / memory deficits
Intervention	1. Restitution group 2. Compensation group 3. Attention placebo group
Intervention type	Other
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 study start date	24/05/2004
Completion date	31/01/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	At least 60 patients in each group (restitution group, compensation group, attention placebo group) = 180.
Key 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.
Key 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).
Date of first enrolment	24/05/2004
Date of final enrolment	31/01/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Nottingham

Nottingham
NG7 2RQ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

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

No information available

Added July 2008:

No information available

Stroke Association (UK) (AHP Research Bursary)
Private sector organisation / Associations and societies (private and public)

Location: United Kingdom

Remedi (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): Remedi UK, Remedi, UK, RemediRj
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2012		Yes	No
Results article	results	19/09/2016		Yes	No

Editorial Notes

21/02/2018: Publication reference added.