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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02308696
Other study ID # 2014-1013
Secondary ID 000001
Status Completed
Phase N/A
First received
Last updated
Start date March 2015
Est. completion date December 2017

Study information

Verified date September 2019
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 456
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Intervention

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.
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

Locations

Country Name City State
United States Jewish Family Service Los Angeles California
United States University of Wisconsin Madison Wisconsin
United States Aliance For Children and Families Milwaukee Wisconsin
United States Community Place of Greater Rochester Rochester New York
United States Alpert Jewish Family and Children's Service West Palm Beach Florida

Sponsors (6)

Lead Sponsor Collaborator
University of Wisconsin, Madison Alliance for Children and Families, Alpert Jewish Family And Childrens Service, Community Place, Jewish Family Service of Los Angeles, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Hospitalizations, Emergency Department Visits, and Urgent Care Visits Investigators will ask participants to report their hospitalizations, ED and Urgent Care visits over the course of a 1 year follow up 1 year
Secondary Health Status and Quality of Life as Assessed by the Short Form-12 Question Physical Component Summary (SF-12 PCS) and the Short Form-12 Mental Component Summary (SF-12 MCS). Investigators will use the Short Form-12 question Physical Component Summary (SF-12 PCS) and the Short Form-12 Mental component Summary (SF-12 MCS) to measure physical and mental health status. Summary scores range from 0-100, with higher scores indicating a better self-reported level of health. 1 year
Secondary Depressive Symptoms as Assessed by the 10 Item Version of the Center of Epidemiologic Studies-Depression Scale Investigators will use the 10 item version of the Center of Epidemiologic Studies-Depression scale to assess depressive symptoms. The possible range of scores is 0 to 10, with a score of zero indicating no depressive symptoms and a score of 10 indicating the most depressive symptoms 1 year
Secondary Anxiety Symptoms as Assessed by the 5-item Version of the Geriatric Anxiety Inventory Short Form Investigators will use the 5-item version of the Geriatric Anxiety Inventory Short Form to measure anxiety symptoms. The scale is 0 to 5, with 0 points indicating zero anxiety symptoms and 5 indicating the most anxiety symptoms. 1 year
Secondary Loneliness as Assessed by the Short Scale for Measuring Loneliness in a Large Survey Investigators will use the Short Scale for Measuring Loneliness in a large survey. Three item measure with a three-point response scale from 1-3, with a score of 1 indicating the least loneliness and a score of 3 indicating the most loneliness. 1 year
Secondary Self-Efficacy as Assessed by the General Self-efficacy Scale to Measure an Individual's Sense of Perceived Self-efficacy. Investigators will use the General Self-efficacy Scale to measure an individual's sense of perceived self-efficacy. The total score ranges between 1 and 4, with 1 indicating low self-efficacy and 4 indicating high self-efficacy. 1 year
Secondary Resilience as Assessed by the Brief Resilience Scale Investigators will use the Brief Resilience Scale to measure the ability of individuals to bounce back from stress. Six item scale scored from 1-5, with a score of 1 indicating low resilience and a score of 5 indicating high resilience. 1 year
Secondary Social Support as Assessed by the 8-item Medical Outcomes Study Social Support Survey Investigators will use the 8-item medical outcomes study social support survey to measure social support. Scored from 1-5, and a score of 1 indicates lower levels of social support while a score of 5 indicates higher levels of social support. 1 year
Secondary Mobility Disability as Assessed by the Rosow-Breslow Scale The Rosow-Breslow scale is a composite measure of mobility disability. The composite score ranges from 0 to 3 with higher scores indicating greater disability. 1 year
Secondary Physical Health as Assessed by the NAGI Test The NAGI test is a nine-item instrument scored from 1-5, with higher scores indicating less physical health. 1 year
Secondary Medical Conditions as Assessed by the Medical Conditions Questionnaire (MCQ) Medical Conditions Questionnaire has 9 yes/no questions on whether or not participants have ever had a condition like heart disease, cancer, diabetes, etc. It ranges from 0 to 9, with 0 indicating better overall health and 9 indicating poor overall health. 1 year
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