A pilot trial of devices monitoring symptoms of Parkinson’s disease

• Register: ISRCTN
• Last refreshed on: 15 March 2021
• Main ID: ISRCTN17396879
• Date of registration: 15/03/2017
• Prospective Registration: Yes
• Primary sponsor: University of Surrey
• Public title: A pilot trial of devices monitoring symptoms of Parkinson’s disease
• Scientific title: PD_Manager: mHealth platform for Parkinson’s disease management
• Date of first enrolment: 17/10/2017
• Target sample size: 200
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN17396879
• Study type: Interventional
• Study design: Multi-centre non-blinded randomised controlled pilot study (Treatment)
• Phase: Not Specified

Countries of recruitment

Greece, Italy, United Kingdom

Contacts

• Name: Morro Touray

• Name: Heather Gage

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease
Nervous System Diseases
Parkinson's Disease

Intervention(s)

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

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

643706

Source(s) of Monetary Support

European Commission

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 30/06/2018