Condition category
Nervous System Diseases
Date applied
17/04/2014
Date assigned
17/04/2014
Last edited
20/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Parkinson's disease is a common, progressive condition that affects the body's nervous system. Over time people with Parkinson's disease are likely to become less steady, less able to move around within their homes and outside and more prone to falls. Although drugs are available to treat the symptoms of Parkinson's disease, reduced balance control and falls do not respond to drugs as well as some other symptoms respond. There is some evidence that physiotherapy can help but to date there are insufficient research findings to quantify the benefits for people with Parkinson's disease. This study is aimed at quantifying these benefits together with the costs incurred and any health service cost savings. PDSAFE is a novel personalised treatment based on the latest published research evidence and our extensive experience of managing the movement and stability problems of people with Parkinson's disease. Our main question is, do people with Parkinson's disease who follow PDSAFE exercises and fall prevention strategies fall less often than those who do not during the 6 months of treatment?

Who can participate?
Patients with Parkinson's disease who live at home and have experienced at least one fall in the previous 12 months.

What does the study involve?
Participants will be asked to record how many times they fall using a monthly diary sheet for 3 months. Participants will then be randomly allocated to one of two groups: intervention or control. The intervention group will participate in PDSAFE, a personalised home-based programme of exercises and strategies for fall prevention to be delivered by physiotherapists. The control group will receive usual care and a DVD with a relaxation programme. Participants will be asked to record how many times they fall using a monthly diary sheet for 12 months.

What are the possible benefits and risks of participating?
There will be no direct benefit to participants that take part in the study, although they may enjoy completing the exercises and being more active. However, it is hoped that the data collected will allow us to define the benefits of PDSAFE, in terms of reducing falls and improving balance of people with Parkinson’s. The cost of PDSAFE will be assessed using information about the treatment delivery costs. This information will be used to further develop the treatment and enhance clinical services. Answering questions from questionnaires can sometimes cause distress but we do not anticipate any disadvantage or risks. Participants do not have to answer any questions or participate in activities they don’t wish to and can stop at any point. It is possible that taking part in exercises and/or assessments can cause instability and put people off balance. Participants do not have to practice any exercises or do any assessments they feel unsure about. A researcher will be present during the assessments to help ensure patient safety.

Where is the study run from?
We aim to recruit from four areas in the South of England: Southampton, Bournemouth, Portsmouth, and Exeter.

When is the study starting and how long is it expected to run for?
From May 2014 to October 2015.

Who is funding the study?
NIHR Health Technology Assessment Programme (UK).

Who is the main contact?
Dr Kim Chivers-Seymour
Kimchivers.seymour@soton.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kim Chivers-Seymour

ORCID ID

Contact details

Faculty of Health Sciences
Southampton General Hospital
Level E
Centre Block
Southampton
SO16 6YD
United Kingdom
-
Pdsafe@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16512; HTA 10/57/21

Study information

Scientific title

A randomised controlled trial of the effectiveness of PDSAFE to prevent falls among people with Parkinson's disease

Acronym

PDSAFE

Study hypothesis

PDSAFE is a novel personalised treatment (PDSAFE) based on the latest published research evidence and our extensive experience of managing the movement and stability problems of people with Parkinson's disease. Our main question is, do people with Parkinson's disease who follow PDSAFE (exercises and fall prevention strategies) fall less than those who do not during the 6 months of treatment?

More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=16512 and http://www.nets.nihr.ac.uk/projects/hta/105721
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0005/97358/PRO-10-57-21.pdf

On 20/07/2015 the overall trial end date was changed from 30/04/2016 to 01/07/2017.

Ethics approval

NRES Committee South Central - Hampshire B, 10/02/2014, ref: 14/SC/0039

Study design

Randomised; Interventional; Design type: Process of Care

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Topic: Dementias and neurodegeneration; Subtopic: Parkinson's Disease; Disease: Parkinson's disease

Intervention

We will recruit 600 to the pre-randomisation falls collection period, we estimate with drop outs approximately 540 will be randomly allocated to one of two groups; intervention or control. Allocation will be stratified by centre and allocated in blocks with random size of 2, 4,6 or 8. The treating therapist will access allocation on the CTU website.

All participants will have usual care. The control group will receive a standardised DVD with a relaxation programme. The experimental group will participate in PDSAFE, a personalised home-based programme of exercises and strategies for fall prevention to be delivered by physiotherapists with specific training in the intervention and use of DVD and tablet computer technology. The novelty of the treatment lies in both the content (disease-specific exercises and strategies for limiting instability, use of motor relearning and cognitive awareness) and delivery (personalised feedback using DVD for adherence and self-management). The programme comprises:
1. Exercises for balance, gait and muscle weakness
2. Strategies for reducing freezing, encouraging stability and gait efficacy
3. Feedback model to promote learning and adherence

Personal sessions with required exercises and will be recorded on DVD and returned so information and instructions can be replayed at home; DVD will be developed with the PwPD. The frequency of the intervention sessions will be faded over time, one hour twice a week for 2 month, once a week for 2 months followed by once a month for 3 months. The control group will receive usual care and a DVD with a relaxation programme.

Those who meet the inclusion criteria will be asked to prospectively record fall events using a monthly diary sheet for 3 months between recruitment and randomisation. These findings will be used for comparison with post-intervention fall rate. The assessments will take place in participants homes at baseline, 3, 6 and 12 months post-randomisation and will be completed by the assessor who will be blinded to group allocation. At baseline a medical history structured to include co-morbidities will be taken, disease severity, medication and hand grip will be recorded.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Risk of repeat falling between 0-6 months. Fall data will be collected through self-completed monthly diary sheets from baseline to 12 months post-randomisation.

Secondary outcome measures

Secondary outcomes will include:
1. Risk of repeat falling 6-12 months
2. Rate of falling 0-6 and 6-12 months
3. Injurious falls and near falls (from the fall diary)
4. A measure of balance, turning, mobility and quality of life
5. Individual levels of activity will be recorded using the Phone-FITT questionnaire

Overall trial start date

01/05/2014

Overall trial end date

01/07/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1.They have a confirmed diagnosis of Parkinson's disease
2. Live at home
3. Have experienced at least one fall in the previous 12 months
4. Able to give informed consent
5. Able to understand and follow commands
6. Able to complete a programme of exercises
7. Be willing to participate
Target Gender: Male & Female; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 600; UK Sample Size: 600;

Participant exclusion criteria

People who live in nursing homes and those who are not independently mobile, i.e. in need of assistance to walk inside or rated the highest (worst) on the Hoehn & Yahr disease severity scale, will be excluded.

Recruitment start date

01/07/2014

Recruitment end date

30/04/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southampton General Hospital
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

Southampton University Hospitals NHS Trust (UK)

Sponsor details

Public Health & Medical Statistics
Mailpoint 805
Southampton
SO16 6YD
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme; Grant Codes: RHM MED 1159

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Findings will be disseminated to academic audiences through publications in academic journals and presentations at academic conferences. Dissemination to practitioners will focus on articles in practitioner-orientated publications and presentations at practitioner-orientated conferences. Dissemination to people affected by Parkinson’s disease (participants, service users and carers) and voluntary workers will be achieved using printed and web-based materials through organisations and networks such as Parkinson’s UK and DeNDRoN.

Please contact the Chief Investigator to discuss data sharing opportunities.

Intention to publish date

01/11/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25971244

Publication citations

Additional files

Editorial Notes