Condition category
Nervous System Diseases
Date applied
19/12/2016
Date assigned
15/03/2017
Last edited
05/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Parkinson’s disease (PD) is a long-term medical condition which is caused by the gradual loss of nerve cells (neurons) in a part of the brain called the substantia nigra. These neurons are normally responsible for producing dopamine, a chemical messenger (neurotransmitter) which carries signals around the brain that help to coordinate movement. In people suffering from PD, these neurons gradually die over time, causing the level of dopamine in the brain to gradually fall. As the levels of dopamine become lower, the brain is unable to coordinate movement as effectively, causing many troublesome symptoms that affect their ability to move, and many other aspects of their lives, including swallowing and speaking. These symptoms fluctuate a lot making it difficult for health professionals to assess the nature of the problems of individual patients and make appropriate treatment decisions. The PD_Manager project has designed some devices that patients can wear that will continuously monitor their symptoms and provide detailed information to health professionals that may help them to identify more effective management strategies. These devices, which include an insole worn in shoes and a wristband, linked to a smart phone, have been tested on people with Parkinson's in a hospital setting. The aim of this study is to test whether people with Parkinson's living in their own homes to use and evaluate the devices and if doctors find the information obtained more useful than traditional symptom diaries.

Who can participate?
Parkinson’s disease patients and their live-in carers.

What does the study involve?
Those agreeing to participate are given an appointment to attend the hospital to meet a Parkinson’s disease specialist nurse who collects some basic information about their condition and background. Participants are then randomly allocated to one of two groups who are asked to monitor their symptoms for two weeks using either PD_Manager or by recording their symptoms in diaries. Those allocated to the PD_Manager group are given instructions on the use and maintenance of all the devices, and a phone number to call for assistance, if needed. Those allocated the diaries are also given necessary instructions on how to complete them. At the end of the two weeks, participants return to the hospital for a consultation with the Parkinson's specialist doctor. All the data gathered by the PD_Manager devices or by the symptom diary is available to the doctor who assesses the information and implements any changes in treatment or referrals that may be indicated. The research team then asks patients, carers and doctors for their views on the PD_Manager devices and the diaries, especially how easy they are to use and how useful the information is for determining the treatment for people with Parkinson's.

What are the possible benefits and risks of participating?
Patients with PD in both groups groups will benefit from some additional monitoring of their symptoms and consultation with a specialist doctor which they would not otherwise receive. There are no risks to participants in the intervention group because the devices have previously been tested and found safe and acceptable to patients. Participants will be reimbursed for any reasonable out of pocket expenses, such as their trips to the hospital for the purposes of their research.

Where is the study run from?
1. Royal Surrey County Hospital (UK)
2. St Peter's Hospital (UK)
3. University of Ioannina (Greece)
4. IRCCS Fondazione Opsedale San Camillo (Italy)

When is the study starting and how long is it expected to run for?
August 2016 to December 2017

Who is funding the study?
European Commission (Belgium)

Who is the main contact?
1. Professor Heather Gage (scientific)
h.gage@surrey.ac.uk
2. Mr Morro Touray (public)
m.touray@surrey.ac.uk

Trial website

http://www.parkinson-manager.eu/

Contact information

Type

Scientific

Primary contact

Prof Heather Gage

ORCID ID

http://orcid.org/0000-0002-2049-9406

Contact details

Surrey Health Economics Centre
University of Surrey
Guildford
GU2 7XH
United Kingdom
+44 1483 68 6948
h.gage@surrey.ac.uk

Type

Public

Additional contact

Mr Morro Touray

ORCID ID

http://orcid.org/0000-0002-1509-6194

Contact details

Surrey Health Economics Centre
University of Surrey
Guildford
GU2 7XH
United Kingdom
+44 1483 68 8614
m.touray@surrey.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

643706

Study information

Scientific title

PD_Manager: mHealth platform for Parkinson’s disease management

Acronym

PD_Manager

Study hypothesis

PD_Manager designed devices (insole, wristband and smartphone) are a more cost-effective form of collecting such timely, reliable and accurate information from patients about their symptoms, compared to the use of traditional diaries.

Ethics approval

NHS Health Research Authority, South East Coast - Surrey Research Ethics Committee, 11/05/2017, ref: 17/LO/0574

Study design

Multi-centre non-blinded randomised controlled pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

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

Condition

Parkinson's Disease

Intervention

Baseline data will be collected by a specialist nurse by interview with the person with Parkinson’s and the carer and through reference to the clinical records. Participants will then be randomised to receive either PD_Manager devices (the intervention) or to be in the control group (symptom diary / no PD-manager). A researcher will provide the symptom diary and give full information about how they are to be used. An appointment for the follow up visit at the end of testing (two weeks later) will be made at a time convenient for the participants.

The PD_Manager mHealth intervention comprises a smart phone, a wristband, a pair of sensor insoles and a knowledge platform. The devices are unobtrusive. Their wearability, sensitivity and reliability have already been tested previously. Data that will be captured include: motor symptoms in legs (insoles) and arms (wristband); speech quality (smartphone); emotional state, cognition, nutrition and medication adherence (apps on smartphone). The PD_Manager platform includes an education section containing videos and animations on symptoms and tips and other relevant information regarding personal care and how to cope with daily life challenges. During the 14 day trial, data from the devices and apps will be sent via a cloud medium in a secure and encrypted manner to the clinician’s hospital computers. The servers where the information in the cloud platform is stored is based in the UK and operated in accordance with the data protection act. Data will also be accessible from the clinician’s mobile phone.

Participants from the control group will be asked to complete a symptom diary for recording motor fluctuations and the other symptoms that are captured by the PD_Manager devices over a 14 day period.

At the end of the two week period, participants will return to the clinic for a consultation. For patients in the intervention group, the responsible clinician will review reports from the devices with relevant information and with management suggestions from the PD_Manager software. On the basis of this information, the clinician will be able to decide if modification to the patient’s management plan is required. In the control group, the clinician will be able to modify the patient’s management plan according to the information captured through the symptom diaries. For both groups, the information may also give rise to referrals to other therapists such as speech and language therapist, dietician, occupational therapist and physiotherapists.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Clinician:
1. Usefulness and value of information from PD_Manger versus symptom diary is measured using a purposefully designed questionnaire at a final interview with a clinician after all participants have completed the trial
2. Confidence/reliability of information is measured using a purposefully designed questionnaire at a final interview with a clinician after all participants have completed the trial
3. Acceptability and usefulness in clinical practice is measured using a purposefully designed questionnaire at a final interview with a clinician after all participants have completed the trial
4. Change in care plan is recorded by the clinician on the case report form of the person with Parkinson’s at the follow-up consultation with the clinician

Secondary outcome measures

1. Acceptability of the respective components of PD_Manager / symptom diary is measured using a purposefully designed questionnaire at the final interview which will be immediately after the follow-up consultation with the clinician
2. Ease of use is measured using a purposefully designed questionnaire at the final interview which will be immediately after the follow-up consultation with the clinician
3. Comfort is measured using a purposefully designed questionnaire at the final interview which will be immediately after the follow-up consultation with the clinician

Economic Analysis:
Cost of PD Manager (technology, user training and troubleshooting, clinician time) vs symptom diary is measured using data obtained from the device manufacturers, study records and observations at the end of the study.

Overall trial start date

01/08/2016

Overall trial end date

31/03/2018

Reason abandoned

Eligibility

Participant inclusion criteria

People with Parkinson’s and caregivers will be recruited as dyads. The inclusion criteria for people with Parkinson’s are:
1. Diagnosis of idiopathic Parkinson’s disease according to the UK Brain Bank Criteria;
2. Hoehn & Yahr disease stage 3 in OFF state
3. Presence of motor fluctuations with an average of at least 2 hours of OFF state during the day;
4. Has a live-in carer who is willing to take part in the study
5. Aged 18 years and over

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 (England - 20; Greece - 20; and Italy - 160)

Participant exclusion criteria

1. Presence of severe cognitive impairment (Parkinson’s Disease Dementia)
2. Co-morbidities with stroke or other brain disease
3. Absence of a caregiver living with the patient
4. No WiFi at home
5. Unable to understand English language

Recruitment start date

17/10/2017

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Greece, Italy, United Kingdom

Trial participating centre

Royal Surrey County Hospital
Egerton Road
Guildford
GU2 7XX
United Kingdom

Trial participating centre

St Peter's Hospital
Guildford Road
Chertsey
KT16 0PZ
United Kingdom

Trial participating centre

University of Ioannina
Dept. of Materials Science and Engineering Medlab, Panepistemioypole Panepistemio Ioannino
Ioannina
45110
Greece

Trial participating centre

IRCCS Fondazione Opsedale San Camillo
Via Alberoni 70
Venezia
30126
Italy

Sponsor information

Organisation

University of Surrey

Sponsor details

Staghil Campus
Guildford
GU2 7XH
United Kingdom
+44 1483 68 3499
RIGO@surrey.ac.uk

Sponsor type

University/education

Website

http://www.surrey.ac.uk/research

Funders

Funder type

Government

Funder name

European Commission

Alternative name(s)

EC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Results and Publications

Publication and dissemination plan

The plans are to publish the results in relevant journals. As to which particular journal will be decided later. The results are expected to be published around December 2017. The results will also be presented in various conferences within and outside the European Union.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/10/2017: The recruitment dates were updated from 01/07/2017-30/09/2017 to 17/10/2017-31/12/2017. 31/08/2017: Ethics approval has been added. Overall trial end date has been changed from 31/12/2017 to 31/03/2018. The recruitment dates were updated from 01/03/2017-30/06/2017 to 01/07/2017-30/09/2017.