Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573762
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Home-Based Monitoring in Parkinsons Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Remote Monitoring Using Commercially Available Activity Trackers and Computer Vision Provides a Holistic Low-cost Assessment of Parkinsons Disease Symptoms
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parkinsons 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
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 Parkinsons disease Group 2 will be patients with a recent within 6 months diagnosis of Parkinsons disease
Group 1 Newly Referred will attend a baseline visit where the following data will be collected
Unified Parkinsons 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 Parkinsons 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 participants 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 TeamsZoom 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 Parkinsons 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 participants 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 TeamsZoom 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 Parkinsons 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
Group 1 Newly Referred will attend a baseline visit where the following data will be collected
Unified Parkinsons 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 Parkinsons 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 participants 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 TeamsZoom 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 Parkinsons 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 participants 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 TeamsZoom 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 Parkinsons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None