Telemedicine Intervention to Improve Cognitive Function
A Telemedicine Intervention to Improve Cognitive Function in Patients With PD
1 other identifier
interventional
160
1 country
1
Brief Summary
This project is investigating whether a home-based exercise program will reduce cognitive decline in patients with Parkinson's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2014
CompletedFirst Posted
Study publicly available on registry
September 25, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedResults Posted
Study results publicly available
July 24, 2019
CompletedJuly 24, 2019
May 1, 2019
3.5 years
September 22, 2014
May 20, 2019
May 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 6
The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 6-month - Score at Baseline.
Baseline and 6 months
Secondary Outcomes (2)
Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 12
Baseline and 12 months
Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 18
Baseline and 18 month
Study Arms (2)
Physical Activity
EXPERIMENTALStructured walking program
Control
ACTIVE COMPARATORHealth education attention control
Interventions
Eligibility Criteria
You may qualify if:
- Physician diagnosis of idiopathic, typical Parkinson's disease (PD)
- At least 2 of 3 cardinal signs of PD
- Response to dopaminergic medication
- Mild cognitive impairment
You may not qualify if:
- Angina pectoris
- History of myocardial infarction within 6 months
- History of ventricular dysrhythmia requiring current therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. David Sparrow
- Organization
- VA Boston Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
David W Sparrow, DSc
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2014
First Posted
September 25, 2014
Study Start
December 1, 2014
Primary Completion
May 15, 2018
Study Completion
September 30, 2018
Last Updated
July 24, 2019
Results First Posted
July 24, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share