sing a wearable smartwatch diary to improve patient’s understanding of Parkinson´s disease

Not Applicable

Completed

• Conditions: Parkinson´s disease; Nervous System Diseases

• Registration Number: ISRCTN17817642
• Lead Sponsor: Västra Götaland Regional Council

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-09
• Study Completion: 2024-01-30
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Parkinson's disease for no more than 8 years, with 4-6 doses of levodopa per day and experiencing some symptom fluctuation relieved by medication

Exclusion Criteria

Presence of dementia or other limitations that, according to the investigator, precludes participation due to inability to follow the protocol, OR not possible to adjust total daily LED by +/10% or more , as determined by the patients regular managing physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Qualitative structured interview at 2-4 weeks of intervention will be used to evaluate the sense of empowerment in patients.

Secondary Outcome Measures

Name	Time	Method
1. Patient reported symptom burden will be measured using Patient Reported Outcomes in Parkinson’s disease” (PRO-PD) at baseline and at the last visit (4-6 weeks)<br>2. Patient reported disease specific health related quality of life will be measured using Parkinson Disease Quality of life 8 Question questionnaire”, (PDQ8) at baseline and at the last visit (4-6 weeks)<br>3. Patient reported health related quality of life will be measured using EuroQoL Eq5D5L at baseline and at the last visit (4-6 weeks)<br>4. Patient reported time in ON and OFF and severity of dyskinesia and OFF-related symptoms will be measured with the ON-OFF” - score (as reported in the MDS-UPDRS part IV) at baseline and at the last visit (4-6 weeks)<br>5. The patient experienced effect of education will be assessed with the Health Education Impact Questionnaire (heiQ) at 2-4 weeks of intervention.<br>6. Patient´s global impression of change (PGIC) will be assessed at the last visit (4-6 weeks).