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

Prospective open interventional case-control study of the effect of using a smartwatch diary on patient empowerment in Parkinson´s disease evaluated by qualitative interviews and questionnaires

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17817642

Enrollment

Registered

2023-06-09

Start date

2022-10-17

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson´s disease Nervous System Diseases

Interventions

Intervention includes the availability of online teaching modules to improve knowledge about symptom fluctuations and their treatments, the use of a wrist-born digital diary, Parkinson Smartwatch® and

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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) 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) 3. Patient reported health related quality of life will be measured using EuroQoL Eq5D5L at baseline and at the last visit (4-6 weeks) 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) 5. The patient experienced effect of education will be assessed with the “Health Education Impact Questionnaire (heiQ) at 2-4 weeks of intervention. 6. Patient´s global impression of change (PGIC) will be assessed at the last visit (4-6 weeks).	—

Measure

Time frame

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) 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) 3. Patient reported health related quality of life will be measured using EuroQoL Eq5D5L at baseline and at the last visit (4-6 weeks) 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) 5. The patient experienced effect of education will be assessed with the “Health Education Impact Questionnaire (heiQ) at 2-4 weeks of intervention. 6. Patient´s global impression of change (PGIC) will be assessed at the last visit (4-6 weeks).

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Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026