Clinical trial NCT06573762: Home-Based Monitoring in Parkinson's Disease
Official title: Remote Monitoring Using Commercially Available Activity Trackers and Computer Vision Provides a Holistic, Low-cost Assessment of Parkinson's Disease Symptoms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be drawn from the patients seen at the UIHC Movement Disorders Clinic.

Brief summary: The goal of this observational study is to learn about the usefulness of automated analysis of speech, physical activity measures tracked using wearable devices at home, and tremor detection measured using computer-vision analysis of smartphone video to detect impairments related to Parkinson's disease and improve prediction of one-year progression.

Participants will attend a short research visit at the University of Iowa. During this visit, they will make a video recording using a smartphone of them performing a fine motor task and audio recordings of pre-written text. They will be provided with an activity tracker and asked to wear it at home for four weeks. After four weeks, a video visit will be conducted and the speech and video tasks will be repeated.

Detailed description: Two groups of participants will be recruited. Group 1 will be patients newly referred to the Movement Disorders clinic for evaluation of possible Parkinson's disease. Group 2 will be patients with a recent (within 6 months) diagnosis of Parkinson's disease.

Group 1 (Newly Referred) will attend a baseline visit where the following data will be collected:

* Unified Parkinson's Disease Rating Scale (UPDRS). The motor assessment tasks will be recorded using an iPad.
* Montreal Cognitive Assessment (MoCA).
* Cognitive function assessment using NIH Toolbox.
* Diagnosis made at the Movement Disorders Clinic (PD or not PD).
* SF-20 quality of life assessment. (Short Form 20)
* PDQ-39 quality-of-life assessment. (Parkinson's Disease Questionnaire 39)
* Tongue and lip strength using the Iowa Oral Pressure Instrument.
* Cognitive function assessment using NIH Toolbox.
* Audio recordings of:

  * Diadochokinesis (DDK) assessment.
  * Vowel prolongation assessment.
  * Sentence Intelligibility Test.
  * Reading the Grandfather, Bamboo, and Rainbow passages.
  * Recording of conversational speech.

Participants will be provided with an activity tracker and a research team member will help install any required apps on the participant's phone, configure and connect the activity tracker, provide a basic overview of how the app and tracker work, and answer any additional questions the participant may have.

The participant will then wear the activity tracker at home for 4 weeks. Text messages reminders will be sent following days with non-wear (no recorded heart rate or steps for multiple hours throughout the day) as a reminder to increase wear time.

At 4 weeks, the participant will complete a video visit using Microsoft Teams/Zoom with a study team member and the study participant. During the video visit, a recording of three different fine-motor skill tasks used in the UPDRS will be made. During the call, the study team member will provide coaching and direct the participant to repeat the audio and UPDRS fine motor task assessment at home while recording the video visit. At the end of the video visit, research team member will also collect questions about the ease and willingness to use the activity tracker and video call for disease monitoring and any open-ended comments the participant wishes to provide. This concludes the participants involvement in the study.

Group 2 (Recently Diagnosed) will attend a baseline visit where the following data will be collected:

* Unified Parkinson's Disease Rating Scale (UPDRS). The motor assessment tasks will be recorded using an iPad.
* Montreal Cognitive Assessment (MoCA).
* Cognitive function assessment using NIH Toolbox.
* Diagnosis made at the Movement Disorders Clinic (PD or not PD).
* SF-20 quality of life assessment.
* PDQ-39 quality-of-life assessment.
* Tongue and lip strength using the Iowa Oral Pressure Instrument.
* Cognitive function assessment using NIH Toolbox.
* Audio recordings of:

  * Diadochokinesis (DDK) assessment.
  * Vowel prolongation assessment.
  * Sentence Intelligibility Test.
  * Reading the Grandfather, Bamboo, and Rainbow passages.
  * Recording of conversational speech.

Participants will be provided with an activity tracker and a research team member will help install any required apps on the participant's phone, configure and connect the activity tracker, provide a basic overview of how the app and tracker work, and answer any additional questions the participant may have.

The participant will then wear the activity tracker at home for 4 weeks. Text messages reminders will be sent following days with non-wear (no recorded heart rate or steps for multiple hours throughout the day) as a reminder to increase wear time.

At 4 weeks, the participant will complete a video visit using Microsoft Teams/Zoom with a study team member and the study participant. During the video visit, a recording of three different fine-motor skill tasks used in the UPDRS will be made. During the call, the study team member will provide coaching and direct the participant to repeat the audio and UPDRS fine motor task assessment at home while recording the video visit. At the end of the video visit, research team member will also collect questions about the ease and willingness to use the activity tracker and video call for disease monitoring and any open-ended comments the participant wishes to provide.

At 11 months, the participant will be contacted to schedule a one-year research visit. Many patients return on 3-6 month intervals to the UIHC Movement Disorders Clinic and the research visit will ideally coordinate the participants routine visit for care.

At the one-year encounter, which will be an in-person research visit, the following data elements will be collected:

* Unified Parkinson's Disease Rating Scale (UPDRS).
* Montreal Cognitive Assessment (MoCA).
* Cognitive function assessment using NIH Toolbox.
* SF-20.
* PDQ-39 quality-of-life assessment.

Additionally, the research team will solicit any open-ended feedback the participant wants to share with the study team about their experience being in the study.

Eligibility criteria: Group 1: People newly referred with possible Parkinson's disease

Inclusion Criteria

1. Newly referred to UIHC Movement Disorders Clinic

Exclusion Criteria

1. Prior diagnosis of Parkinson's disease
2. Confined to wheelchair or bed
3. Non-English speaking
4. Prisoner status
5. Inability to provide own informed consent
6. Phone unable to support the Fitbit app

Group 2: People with a recent diagnosis of Parkinson's disease

Inclusion Criteria

1. Patient of UIHC Movement Disorders Clinic
2. Diagnosed with Parkinson's disease

Exclusion Criteria

1. First diagnosed \> 6 months ago
2. Confined to wheelchair or bed
3. Non-English speaking
4. Prisoner status
5. Inability to provide own informed consent
6. Phone unable to support the Fitbit app

Primary outcomes:
measure: Number of Patients with a Diagnosis of Parkinson's Disease
timeFrame: Baseline
measure: Change in Fine Motor Function
timeFrame: Baseline, One Year
measure: Change in Total Cognition Composite Function
timeFrame: Baseline, One Year
measure: Change in Total Crystallized Cognition Function
timeFrame: Baseline, One Year
measure: Change in Total Fluid Cognition Function
timeFrame: Baseline, One Year
measure: Change in Montreal Cognitive Assessment Scores
timeFrame: Baseline, One Year
Secondary outcomes:
measure: Change in Short Form Survey 20 (SF-20) Health Quality of Life
timeFrame: Baseline, One Year
measure: Change in Parkinson's Disease Questionnaire 39 (PDQ-39) Quality of Life
timeFrame: Baseline, One Year
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Jacob Simmering, PhD
role: PRINCIPAL_INVESTIGATOR
References: