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The Effectiveness of Peer-to-Peer Community Support to Promote Aging in Place

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ClinicalTrials.gov Identifier: NCT02308696
Recruitment Status : Unknown
Verified October 2016 by University of Wisconsin, Madison.
Recruitment status was:  Active, not recruiting
First Posted : December 4, 2014
Last Update Posted : October 20, 2016
Sponsor:
Collaborators:
Community Place
Jewish Family Service of Los Angeles
Alpert Jewish Family And Childrens Service
Alliance for Children and Families
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE December 2, 2014
First Posted Date  ICMJE December 4, 2014
Last Update Posted Date October 20, 2016
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
Number of Hospitalizations, Emergency Department Visits, and Urgent Care visits [ Time Frame: 1 year ]
Investigators will ask participants to report their hospitalizations, ED and Urgent Care visits over the course of a 1 year follow up
Original Primary Outcome Measures  ICMJE
 (submitted: December 2, 2014)
Number of Hospitalizations and Emergency Department Visits [ Time Frame: 1 year ]
We will ask participants to report their hospitalizations over the course of a 1 year follow up
Change History Complete list of historical versions of study NCT02308696 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2014)
  • Health Status and Quality of Life [ Time Frame: 1 year ]
    Investigators will use the 12-item Short Form to measure physical and mental health status
  • Depressive Symptoms [ Time Frame: 1 year ]
    Investigators will use the 10 item version of the Center of Epidemiologic Studies-Depression scale to assess depressive symptoms
  • Anxiety Symptoms [ Time Frame: 1 year ]
    Investigators will use the 5-item version of the Geriatric Anxiety Inventory Short Form to measure anxiety symptoms
  • Loneliness [ Time Frame: 1 year ]
    Investigators will use the Short Scale for Measuring Loneliness in a large survey
  • Self-Efficacy [ Time Frame: 1 year ]
    Investigators will use the General Self-efficacy Scale to measure an individual's sense of perceived self-efficacy.
  • Resilience [ Time Frame: 1 year ]
    Investigators will use the Brief Resilience Scale to measure the ability of individuals to bounce back from stress.
  • Social Support [ Time Frame: 1 year ]
    Investigators will use the 8-item medical outcomes study social support survey to measure social support
Original Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2014)
  • Health Status and Quality of Life [ Time Frame: 1 year ]
    We will use the 12-item Short Form to measure physical and mental health status
  • Depressive Symptoms [ Time Frame: 1 year ]
    We will use the 10 item version of the Center of Epidemiologic Studies-Depression scale to assess depressive symptoms
  • Anxiety Symptoms [ Time Frame: 1 year ]
    We will use the 5-item version of the Geriatric Anxiety Inventory Short Form to measure anxiety symptoms
  • Loneliness [ Time Frame: 1 year ]
    We will use the Short Scale for Measuring Loneliness in a large survey
  • Self-Efficacy [ Time Frame: 1 year ]
    We will use the General Self-efficacy Scale to measure an individual's sense of perceived self-efficacy.
  • Resilience [ Time Frame: 1 year ]
    We will use the Brief Resilience Scale to measure the ability of individuals to bounce back from stress.
  • Social Support [ Time Frame: 1 year ]
    We will use the 8-item medical outcomes study social support survey to measure social support
Current Other Pre-specified Outcome Measures
 (submitted: December 2, 2014)
  • Sociodemographic Variables [ Time Frame: once ]
  • Health Care Utilization Variables [ Time Frame: 1 year ]
  • Behavioral and Physical Health Variables [ Time Frame: 1 year ]
  • Chronic Health Conditions and Medication Use [ Time Frame: 1 year ]
  • Peer-to-peer support variables [ Time Frame: 1 year ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effectiveness of Peer-to-Peer Community Support to Promote Aging in Place
Official Title  ICMJE The Effectiveness of Peer-to-Peer Community Support to Promote Aging in Place
Brief Summary

The investigators' overall objective is to evaluate the effectiveness of peer-to-peer support programs in preventing the necessity of acute health care and nursing home services for older adult populations and in promoting their health and wellness. The investigators' Specific Aims are:

  1. To compare the effectiveness of peer-to-peer community support in preventing hospitalization, emergency department (ED) use, and nursing home placement in an at-risk older adult population relative to standard community services.
  2. To compare the effect of peer-to-peer community support on intermediary measures of health and wellness such as self-rated health, depression, and anxiety relative to standard community services.
Detailed Description

The investigators will accomplish the aims by conducting a longitudinal comparative-effectiveness study in which at-risk older adult study participants in three communities across the US are followed for 12-months. Using a quasi-experimental design, investigators will compare outcomes in those receiving peer-to-peer community support to those receiving standard community services.

At all three sites investigators will include 120 older adults in the peer-to-peer support group and 120 in the standard community services group for a total intervention group size of 360 (120 from each site) and 360 in the control group (120 from each site).

Study Outcomes & Measures To meet the first two aims investigators will (1) compare annualized rates of hospitalization, ED use, and nursing home placement and (2) examine the changes in self-reported health, depression, anxiety, and other measures of well-being in the group receiving peer-to-peer support compared to the group receiving standard community services from baseline to the end of study enrolment. The investigators describe each of our outcomes and additional study measures in detail below. Measures have been translated and used in Spanish and have been shown to be valid or have high reliability in Spanish

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Wellness Programs
  • Hospitalization
  • Emergency Room
Intervention  ICMJE
  • Behavioral: Peer-to-Peer Support
    All three data collection sites run peer-to-peer community support programs. Core program elements include the same program objective, standard definition of who qualifies for peer-to-peer support, the mechanism by which older adults are referred for consideration for peer-support, core elements of training programs for the older adults who volunteer to provide the peer support, and monthly in-service trainings for all volunteers once trained, weekly hours that volunteers spend providing support, and provision of small stipends for volunteers.As they find their role very rewarding, there is very little peer turn-over; the vast majority of peers volunteer for years in this role, until they themselves start requiring services.
  • Behavioral: Standard Community Services
    All three data collection sites will continue to provide standard community services to the older adults that are not enrolled in the peer-to-peer support program
Study Arms  ICMJE
  • Experimental: Peer-to-peer support (non-randomized)
    225 older adults that are currently receiving peer-to-peer support
    Intervention: Behavioral: Peer-to-Peer Support
  • Active Comparator: Standard Services (non-randomized)
    225 older adults will continue receiving standard community services
    Intervention: Behavioral: Standard Community Services
Publications * Not Provided

*   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 Unknown status
Actual Enrollment  ICMJE
 (submitted: October 19, 2016)
457
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2014)
720
Estimated Study Completion Date  ICMJE October 2017
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Overall

    • ≥65 years of age
    • Speaks English or Spanish
    • Lives independently in their community year-round
    • Meet the community defined criterion for receiving peer-to-peer support (at least one of the following)

      • Low income (at or below poverty level)
      • On a fixed income that barely meets their living expenses
      • Social and/or familial isolation
      • Chronic Illness
      • In need of frequent community services or resources. Peer-to-peer support group (must meet the overall inclusion criteria as well as the following)
    • Enrolled in the peer-to-peer support program and have an assigned peer volunteer

Exclusion Criteria:

  • < 65
  • Score ≤ 30 on the Telephone Interview of Cognitive Status (TICS) because they will not have the ability to complete the survey
  • State that it is unlikely that they will receive peer-to-peer support services for at least a year. Individuals who are unlikely to receive at least a year of services include those who need short-term help after a surgery and are likely to return to full functioning and those planning to transition to nursing home care or move away.

    • Currently receiving hospice services
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT02308696
Other Study ID Numbers  ICMJE 000001
2014-1013 ( Other Identifier: UW HSIRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE
  • Community Place
  • Jewish Family Service of Los Angeles
  • Alpert Jewish Family And Childrens Service
  • Alliance for Children and Families
  • Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Elizabeth A Jacobs, MD MPP UMadison
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