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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02128789
Other study ID # 2013-0171
Secondary ID 5P50HS019917-04H
Status Completed
Phase N/A
First received March 26, 2014
Last updated October 26, 2016
Start date June 2011
Est. completion date May 2016

Study information

Verified date October 2016
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Other:
Elder Tree website
Elder Tree is a private, secure information, support and communication website developed for this study.

Locations

Country Name City State
United States University of WI Madison Madison Wisconsin

Sponsors (3)

Lead Sponsor Collaborator
University of Wisconsin, Madison Agency for Healthcare Research and Quality (AHRQ), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of older adult subjects with increased independence and quality of life from baseline to 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 No
Secondary Number of caregiver subjects with improved satisfaction 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 No