Using a wearable smartwatch diary to improve patient’s understanding of Parkinson´s disease
| ISRCTN | ISRCTN17817642 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17817642 |
| Secondary identifying numbers | https://www.researchweb.org/is/vgr/project/279229 |
- Submission date
- 07/10/2022
- Registration date
- 09/06/2023
- Last edited
- 16/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Parkinson’s disease (PD) currently has no curative or disease-slowing treatment, but many symptoms are highly responsive to dopamine replacement therapy, in particular levodopa. A problem with levodopa is that is quickly eliminated from the blood. This has no consequence early in disease when the product of levodopa, dopamine, can still be stored in the brain. However, within 3-8 years of disease the effect of levodopa becomes shorter in duration and less predictable. As a result, symptoms re-occur during the day, so-called fluctuations. Fluctuations to poor symptom relief are called “OFF”. In some patients there is excessive medication effects at times resulting in involuntary movements, so-called “ON with dyskinesia”. The occurrence of either of these states reduces the available time during the day with good treatment effect and is negative for quality of life and daily function. The terms for different treatment states can be difficult to understand and patients often have their own descriptions of the different symptom constellations they can experience. A correct understanding of symptom fluctuations is necessary for treatment adjustments.
The Parkinson Smartwatch system is a wrist-born diary which due to its placement is available during all time awake. Unlike traditional diaries, the patient is only asked to report change in state.
We hypothesize that using the Smartwatch diary after first learning about symptom variations, how Parkinson's drugs act in the body and how medication can be adjusted to obtain a more stable symptom relief will improve the sense of empowerment in PD patients.
Patients will be recruited at the two neurology departments.
Who can participate?
Patients with PD will be recruited at the two neurology departments.
What does the study involve?
Participation involves using an online education platform regarding Parkinson's symptom fluctuations and strategies to reduce them as well as using the Smartwatch to analyze and self-adjust medication within prescribed limits for up to 6 weeks. Participants will undergo a structured interview and fill out patient-reported outcome questionnaires as well as symptom ratings by the investigators.
What are the possible benefits and risks of participating?
Participation involves using an online education platform regarding Parkinson's symptom fluctuations and strategies to reduce them as well as using the Smartwatch to analyze and self-adjust medication within prescribed limits for up to 6 weeks. Participants will undergo a structured interview and fill out patient-reported outcome questionnaires as well as symptom rating by the investigators. Possible benefits of participating are an increased understanding of Parkinson’s disease and tools to better control and adjust medication. The potential risk is that self-adjustment of medication leads to adverse effects. This risk is limited by only using drugs that the participants have experience with and by predefining safe limits of change in medication.
Where is the study run from?
Västra Götaland Regional Council (Sweden)
When is the study starting and how long is it expected to run for?
April 2022 to January 2024
Who is funding the study?
The study is funded by ALF, the agreement between the Swedish government and the health care regions, with Prof Filip Bergquist as the Coordinating investigator
Who is the main contact?
Prof. Filip Bergquist, filip.bergquist@gu.se
Contact information
Principal Investigator
Box 431
Medicinaregatan 13
Gothenburg
40530
Sweden
 ORCID ID |
0000-0002-3437-0267 |
|---|---|
| Phone | +46 702223664 |
| filip.bergquist@pharm.gu.se |
Study information
| Study design | Open prospective interventional study with case-control design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | 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 |
| Study objectives | The use of a wrist-born digital diary, Parkinson Smartwatch improves patient empowerment in persons with Parkinson´s disease with symptom fluctuations |
| Ethics approval(s) | Approved 17/08/2022, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, 750 02, Uppsala, Sweden; +46 10-475 08 00; registrator@etikprovning.se), ref: 2022-03906-01 |
| Health condition(s) or problem(s) studied | Parkinson´s disease |
| Intervention | 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 a predefined medication adjustment interval. The control group will be given a predefined medication adjustment interval, but otherwise standard care. The intervention will continue for 4-6 weeks. |
| Intervention type | Mixed |
| Primary outcome measure | Qualitative structured interview at 2-4 weeks of intervention will be used to evaluate the sense of empowerment in patients. |
| Secondary outcome measures | 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). |
| Overall study start date | 01/04/2022 |
| Completion date | 30/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 14 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 17/10/2022 |
| Date of final enrolment | 15/12/2023 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Göteborg
41345
Sweden
Borås
50182
Sweden
Sponsor information
Government
Neurosjukvården
Blå stråket 7
Göteborg
41345
Sweden
| Phone | +46-31 3421000 |
|---|---|
| filip.bergquist@vgregion.se | |
| Website | http://www.vgregion.se/en/Vastra-Gotalandsregionen/Home/ |
"ROR" |
https://ror.org/00a4x6777 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 16/12/2024 | No | No |
Additional files
Editorial Notes
16/12/2024: The basic results have been uploaded as an additional file.
04/06/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/05/2023 to 15/12/2023.
2. The overall study end date was changed from 30/06/2023 to 30/01/2024.
3. Total final enrolment added.
10/10/2022: Trial's existence confirmed by Swedish Ethical Review Authority (Etikprövningsmyndigheten)
