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Bring Communities and Technology Together for Healthy Aging (ElderTree)

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ClinicalTrials.gov Identifier: NCT02128789
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : October 27, 2016
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE March 26, 2014
First Posted Date  ICMJE May 1, 2014
Last Update Posted Date October 27, 2016
Study Start Date  ICMJE June 2011
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02128789 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bring Communities and Technology Together for Healthy Aging
Official Title  ICMJE Bring Communities and Technology Together for Healthy Aging
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • 65 Years Older
  • Requires IADL Support
  • Past Year History of Falls and/or Hospitalization
Intervention  ICMJE Other: Elder Tree website
Elder Tree is a private, secure information, support and communication website developed for this study.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Elder Tree website
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 29, 2014)
600
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02128789
Other Study ID Numbers  ICMJE 2013-0171
5P50HS019917-04 ( U.S. AHRQ Grant/Contract )
HS019917 ( Other Identifier: Study Team )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • Agency for Healthcare Research and Quality (AHRQ)
Investigators  ICMJE Not Provided
PRS Account University of Wisconsin, Madison
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP