Condition category
Mental and Behavioural Disorders
Date applied
31/03/2015
Date assigned
13/04/2015
Last edited
24/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Parkinson’s disease (PD) is a common condition that causes problems with movement. It also causes memory problems which can develop into dementia. People with a similar condition called Dementia with Lewy Bodies (DLB) also have memory and movement problems. For both conditions drugs are the main form of treatment but they can have bad side-effects and not everyone can take them. Scientists want to develop treatments that do not use drugs so that more people with memory problems can be given them. Cognitive Rehabilitation (CR) is a treatment that focuses on improving memory by helping people to make achievable goals in their daily lives. It has been shown to be useful in Alzheimer’s disease but this has not been tested in PD or DLB. This study aims to find out whether CR can improve memory performance in people with PD and DLB.

Who can participate?
People diagnosed with PD and PD dementia or people diagnosed with DLB.

What does the study involve?
People are randomly divided into three groups. One group has CR, another has a form of relaxation therapy and the third group continues with their usual drug treatment. People taking part choose up to three activities or problems that trouble them and that they wish to improve. The success of the treatment is measured by how the participants feel about achieving their own goals. A number of other measures of success are also used.

What are the possible benefits and risks of participating?
The results of the study will help decide how well CR works compared with relaxation therapy and treatment as usual. The results will also help design larger studies of non-drug treatments that improve memory so that more people with PD or DLB can benefit.

Where is the study run from?
Llandudno General Hospital, BCUHB (main site) and 13 other hospitals in Wales

When is the study starting and how long is it expected to run for?
January 2015 to January 2017

Who is funding the study?
National Institute for Social Care and Health Research (NISCHR) (UK)

Who is the main contact?
1. Dr T Watermeyer (public)
t.watermeyer@bangor.ac.uk
2. Dr JV Hindle (scientific)

Trial website

Contact information

Type

Public

Primary contact

Dr Tam Watermeyer

ORCID ID

Contact details

Bangor University
Brigantia Building
Penrallt Road
Bangor
LL57 2AS
United Kingdom
+44 (0) 1248 383775
t.watermeyer@bangor.ac.uk

Type

Scientific

Additional contact

Dr John V Hindle

ORCID ID

Contact details

Llandudno General Hospital
Hospital Rd
Llandudno
Conwy
Llandudno
LL30 1LB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RFPPB-2012-1020

Study information

Scientific title

COgnitive Rehabilitation for Parkinson's Disease Dementia: a pilot trial

Acronym

CORD-PD

Study hypothesis

This study will trial goal-oriented Cognitive Rehabilitation (CR) in Parkinson's disease (PD) dementia and Dementia with Lewy Bodies (DLB). Goal-oriented CR has been shown to be effective in Alzheimer’s disease (AD) and is now subject to a major multicentre trial (the GREAT study). CR will be compared with treatment as usual for PD and DLB, and a control condition involving relaxation therapy will also be included. All participants will identify areas in which they would like to improve their current functioning or management of difficulties, and those allocated to the CR condition will be able to work with a therapist to address these goals. The hypothesis is that goal performance will improve significantly in the CR group compared with the relaxation therapy or treatment as usual groups.

Other objectives to be addressed:
1. Assess the utility of outcome measures, particularly the goal setting interview, and provide information on effect sizes to inform power calculations for a definitive multi-centre randomised controlled trial of cognitive rehabilitation in PD dementia and DLB
2. Establish whether three arms are needed in a larger trial or whether comparison with treatment as usual is sufficient
3. Explore the utility of routine involvement of therapists in the management of cognitive problems in these conditions to improve access to psychological therapies
4. Investigate the effect of CR on standard cognitive measures of memory and executive function as well as mood and behaviour
5. Investigate the potential transfer of treatment effects into daily life as demonstrated by functional outcome measures and quality of life
6. Investigate the effects of the intervention on carers’ mood, quality of life, stress and health
7. Finally, a pilot assessment of cost-effectiveness will be included in the study in order to test the utility of measures and gain initial data to support the development of a larger trial which will provide definitive evidence on cost effectiveness

Ethics approval

North Wales Research Ethics Committee - West, 24/11/2013, mREC ref: 13/WA/0340

Study design

Non-pharmacological multi-centre single-blind randomised controlled pilot 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

Parkinson's disease dementia and dementia with Lewy bodies

Intervention

Goal setting:
1. All participants will collaboratively agree problem areas which are formulated in up to three personal rehabilitation goals using the Bangor Goal Setting Interview (BGSI). They will rate their own performance on these goals at initial and follow-up assessments, but only the Cognitive Rehabilitation (CR) group will work with a therapist to address these goals.

CR with the therapist:
1. Goals identified at the initial assessment will be communicated to the therapist who will use them as the starting point for therapy and further operationalise and refine them if necessary. Eight individual one hour sessions of CR will be delivered at home over 2 months. Carers will be involved in part of each session where possible. Goals will be introduced one at a time, in a flexible manner depending on rate of progress. The participant and carer will work on the selected goals between sessions following an agreed schedule of activities. The therapist will use a variety of evidence based strategies and supporting components dependent on the nature of the goals set including strategies for managing practical situations and cognitive difficulties and anxiety management. Progress with each goal will be reviewed and the strategies adopted will be adjusted as necessary on a weekly basis. In-session ratings of goal performance will be made by participants, carers and the therapist to evaluate progress.

Comparators:
1. CR will be compared with Relaxation Therapy (RT) and Treatment As Usual (TAU). RT is included as an active control condition involving equivalent therapist time and attention. RT will consist of eight individual sessions of one hour’s duration in participants’ own homes. After an initial ‘getting to know’ you session where the therapeutic model is explained, each session has a theme which includes music, pictures, radio and television, sensory stimulation and humour before a final consolidation. Each session includes consolidation of the last one, a mood checklist and some homework.
2. TAU will consist of usual medication and any other services apart from specific programmes of CR or other cognition-focused intervention. TAU may include routine monitoring by the movement disorder clinic or memory clinic, information provision, attendance at drop-in groups or support groups, or carer participation in support groups.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Participants’ performance and satisfaction on goals, identified through the Bangor Goal-Setting Interview measure are rated at baseline and at follow-up visits (a 2 month post-intervention visit and a 6 month follow-up visit)

Secondary outcome measures

For PD dementia patients these cover the domains of cognition, mood, behaviour, everyday functional activity, motor severity, quality of life, self-efficacy, and carer ratings (where available) of patients’ performance on goals identified during the BGSI interview. Carers’ outcomes will include quality of life, stress and health.

Cognition:
1. Global cognition will be measured using the Addenbrooke's Cognitive Examination-III (ACE-III) (at screening and at the 6-month follow-up visit).
2. Assessments of executive function will be the Trail Making Test (TMT), and the letter fluency tests from the Delis-Kaplan Executive Function System (both measured at each time point).
3. Attention will be assessed using the Test of Everyday Attention (at each time point).
4. Memory will be assessed using the Rivermead Behavioural Memory Test, story recall sub-test (at each time point).

Mood and behaviour:
1. Mood will be assessed at each time point using the Hospital Anxiety and Depression Scale which contains two subscales: anxiety and depression.
2. Behavioural assessment will include delusions and hallucinations measured using the Neuropsychiatric Inventory Questionnaire (this will be measured at the baseline and 6-month follow-up visits).
3. The Unified Parkinson’s Disease Rating Scale will be used to assess the motor symptoms of Parkinsonism in PD and DLB and also assess function and activities of daily living (both will be used at the baseline and 6-month follow-up visits).
4. Quality of life will be assessed in PD and DLB using the abbreviated Parkinson’s disease quality of life scale (PDQ-8) and the WHO Quality of Life – BREF (WHOQOL-BREF) (both will be used at the each time point).
5. The WHOQOL-BREF will also be used for carers (at each time point).
6. In order to assess a general sense of perceived self-efficacy, the potential to influence one’s situation through one’s own actions, the Generalised Self Efficacy Scale will be used at each time-point for both patient and carer participants.
7. Carers’ stress will be assessed using the 15-item dementia-specific Relatives’ Stress Scale, at each time point.

Health economics:
1. Health care utilisation during the study period will be measured using a trial-specific Client Services Receipt Inventory.
2. Cost-effectiveness will be piloted using measures of health status, the Euroqol EQ5D. These will be administered at the baseline and 6-month follow-up visits.

Other information:
1. Gender, age, relationship between person with PD dementia and carer and whether they live together, age of onset of PD, PD dementia, or DLB, Hoehn and Yahr PD severity, medication, educational level, social class, and co-morbidities will be recorded to examine effects of demographic and social variables on treatment efficacy (recorded during screening and baseline visit).

Overall trial start date

01/01/2015

Overall trial end date

01/01/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 22/06/2015:
1. Diagnosis of Parkinson's disease (PD) according to the UK PD Brain Bank Diagnostic Criteria and a diagnosis of PD dementia according to the Movement Disorder Society consensus criteria or
2. Diagnosis of Dementia with Lewy Bodies (DLB) according to the DLB Consortium consensus criteria.
3. Clinical diagnosis of mild to moderate dementia with an ACE-III score of ≤82
4. Participants will preferably have a carer or family member who is willing to participate but this is not an absolute requirement
5. Participants should be on stable medication for their Parkinsonism and cognition (including acetylcholinesterase inhibitors) for four weeks prior to commencement with no changes planned for the duration of the intervention. Any unplanned changes in medication during the intervention will be documented

Previous inclusion criteria:
1. Diagnosis of Parkinson's disease (PD) according to the UK PD Brain Bank Diagnostic Criteria and a diagnosis of PD dementia according to the Movement Disorder Society consensus criteria or;
2. Diagnosis of Dementia with Lewy Bodies (DLB) according to the DLB Consortium consensus criteria.
3. Clinical diagnosis of mild to moderate dementia with an ACE-III score of <80
4. Participants will preferably have a carer or family member who is willing to participate but this is not an absolute requirement
5. Participants should be on stable medication for their Parkinsonism and cognition (including acetylcholinesterase inhibitors) for four weeks prior to commencement with no changes planned for the duration of the intervention. Any unplanned changes in medication during the intervention will be documented

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

45

Participant exclusion criteria

1. Lack of stability of Parkinson's disease (PD) medications, cognitive enhancers or psychotropic medication or substantial additions to medication in the four weeks before the trial or planned changes during the period of the trial
2. Other major psychiatric disorder not related to PD
3. Major depression
4. Other significant neurological disease

Recruitment start date

01/04/2015

Recruitment end date

01/04/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Llandudno General Hospital, BCUHB
Hospital Road, Llandudno, Gwynedd
LL30 1LB
United Kingdom

Trial participating centre

Dolgellau and Barmouth District Hospital
LL40 1NT
United Kingdom

Trial participating centre

Penrhos Stanley Hospital
LL65 2QA
United Kingdom

Trial participating centre

Eryri Hospital
LL48 6LF
United Kingdom

Trial participating centre

Cefni Hospital
LL77 7PP
United Kingdom

Trial participating centre

Gwynedd Hospital
LL57 2PW
United Kingdom

Trial participating centre

Glan Clwyd Hospital
LL18 5UJ
United Kingdom

Trial participating centre

Wrexham Maelor Hospital
LL13 7TD
United Kingdom

Trial participating centre

Bryn Hesketh Memory Clinic
LL29 8AT
United Kingdom

Trial participating centre

Bodnant Memory Clinic
LL57 2PW
United Kingdom

Trial participating centre

Wepre House Hospital
CH5 4HA
United Kingdom

Trial participating centre

Glan traeth Day Hospital
LL18 3AS
United Kingdom

Trial participating centre

Ruthin Community Hospital
LL15 1PS
United Kingdom

Trial participating centre

Holywell Community Hospital
CH8 7TZ
United Kingdom

Sponsor information

Organisation

Betsi Cadwaladr University Health Board

Sponsor details

Mountain View
Penrhos Road
Bangor
LL57 2NA
United Kingdom

Sponsor type

Other

Website

Funders

Funder type

Government

Funder name

National Institute for Social Care and Health Research (NISCHR) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Findings will be published in key scientific and open access journals. The results will be discussed with the Clinical Programme Groups in Medicine and Primary Care and Mental Health and will influence future practice in BCUHB and across Wales and the wider NHS. The PI is the clinical Lead for the Neurosciences Network in BCUHB and any implications for services as a result of this work will be fed back through that group. The results will be disseminated to the Minster of Health and Social Services in Wales via the National Specialist Advisory Groups in Mental Health, Older People and Neurosciences. We will work with Parkinson’s UK and dementia charities to ensure that results reach people with PD and DLB and their family members, and will provide articles for newsletters and websites accessed by people with PD, DLB and their family members. Articles will be published in key practitioner journals (e.g. Journal of Dementia Care, Nursing Times) and presentations will be made at practitioner conferences (e.g.UK Dementia Congress, Parkinson’s Disease Nurse Specialist Association) to target clinical psychologists, therapists and nurses who care for people with PD dementia. The NICE and SIGN Guidelines for PD do not include any evidence on non-pharmacological interventions in cognitive impairment in PD. It is hoped that the results of this study will be included in discussions of cognition-focussed therapies in future iterations of these guidelines.

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27000036

Publication citations

Additional files

Editorial Notes

24/03/2016: Publication reference added. On 21/10/2015 the target number of participants was changed from 60 to 45.