NCT02128789

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

4.9 years

First QC Date

March 26, 2014

Last Update Submit

October 26, 2016

Conditions

Keywords

Older AdultsCaregiversAgingSupport

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Number of caregiver subjects with improved satisfaction

    Change in improved caregiver satisfaction will be assessed at 6, 12 , 18 months

Study Arms (2)

Control Condition

NO INTERVENTION

Subjects receive usual care and support. No study intervention provided

Elder Tree Condition

EXPERIMENTAL

Elder Tree website. Subjects receive usual care, support and access to the study intervention website.

Other: Elder Tree website

Interventions

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

Elder Tree Condition

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • years or older
  • In need of IADL support
  • 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.

You may not qualify if:

  • Under 65 years of age
  • Unable to read English
  • Not a resident of the above listed counties.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of WI Madison

Madison, Wisconsin, 53705, United States

Location

Related Publications (3)

  • Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.

  • 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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2014

First Posted

May 1, 2014

Study Start

June 1, 2011

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations