Parkinson's Disease Nervous System Diseases Parkinson's Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Greece, Italy, United Kingdom