- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02128789
Bring Communities and Technology Together for Healthy Aging (ElderTree)
October 26, 2016 updated by: University of Wisconsin, Madison
Technology has been created to help older adults age well in their homes, but adoption and acceptance have been slow.
The researchers are developing a low-cost web-based technology, called Elder Tree, for older adults and caregivers to address key challenges older adults face, such as loneliness and isolation, falls, loss of driving privileges, relapsing from proven falls prevention strategies, and unreliable home services.
Elder Tree is being developed and tested with older adults and caregivers to identify, 1) usability issues such as font size, navigation and interface (audio, video,text) and 2) content and tailoring issues such as identifying local resources and events.
This study will employ a randomized longitudinal design comparing a control group to an intervention group over a 12-month period.
Investigators hypothesize that older adults using Elder Tree will experience greater independence and quality of life when compared to the control group.
Investigators will use quantitative measures to determine how much our intervention improves: quality of life and health system use.
These measures will help us to determine the cost effectiveness of Elder Tree.
Investigators will recruit and test Elder Tree in 3 Regional Aging and Disability Resource Centers; one urban, one suburban and one rural setting, so to account for environmental and community differences.
The older adult and their caregiver will be randomized to the same treatment group.
Investigators will measure the effect over the 12 month intervention period and a 6 month follow-up period at 18 months.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53705
- University of WI Madison
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 65 years or older
- In need of IADL support
- 1 years history or risk of hospitalization or falls
- Resident of the following counties Milwaukee, WI, Waukesha Wi or Richland County
- Must be able to read English at a 6th grade level.
Exclusion Criteria:
- Under 65 years of age
- Unable to read English
- Not a resident of the above listed counties.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Condition
Subjects receive usual care and support.
No study intervention provided
|
|
Experimental: Elder Tree Condition
Elder Tree website.
Subjects receive usual care, support and access to the study intervention website.
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Elder Tree is a private, secure information, support and communication website developed for this study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of older adult subjects with increased independence and quality of life from baseline to 18 months
Time Frame: Change in independence and quality of life will be assessed at 6, 12 , 18 months
|
Compared to the control group elders using Elder Tree will experience greater independence and quality of life and will have fewer unscheduled clinical and emergency room visits and hospital and nursing home stays.
|
Change in independence and quality of life will be assessed at 6, 12 , 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of caregiver subjects with improved satisfaction
Time Frame: Change in improved caregiver satisfaction will be assessed at 6, 12 , 18 months
|
Compared to the control group, caregivers using Elder Tree will experience improved satisfaction, coping and appraisal.
|
Change in improved caregiver satisfaction will be assessed at 6, 12 , 18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gustafson DH Sr, Kornfield R, Mares ML, Johnston DC, Cody OJ, Yang EF, Gustafson DH Jr, Hwang J, Mahoney JE, Curtin JJ, Tahk A, Shah DV. Effect of an eHealth intervention on older adults' quality of life and health-related outcomes: a randomized clinical trial. J Gen Intern Med. 2022 Feb;37(3):521-530. doi: 10.1007/s11606-021-06888-1. Epub 2021 Jun 7.
- Gustafson DH Sr, McTavish F, Gustafson DH Jr, Mahoney JE, Johnson RA, Lee JD, Quanbeck A, Atwood AK, Isham A, Veeramani R, Clemson L, Shah D. The effect of an information and communication technology (ICT) on older adults' quality of life: study protocol for a randomized control trial. Trials. 2015 Apr 25;16:191. doi: 10.1186/s13063-015-0713-2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
March 26, 2014
First Submitted That Met QC Criteria
April 29, 2014
First Posted (Estimate)
May 1, 2014
Study Record Updates
Last Update Posted (Estimate)
October 27, 2016
Last Update Submitted That Met QC Criteria
October 26, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2013-0171
- 5P50HS019917-04 (U.S. AHRQ Grant/Contract)
- HS019917 (Other Identifier: Study Team)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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