Wellness ProgramsNCT02308696
The Effectiveness of Peer-to-Peer Community Support to Promote Aging in Place
A study testing Peer-to-Peer Support and Standard Community Services in people with Wellness Programs and Hospitalization, run by University of Wisconsin, Madison at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wellness Programs, Hospitalization, Emergency Room
- What is being tested?
- Peer-to-Peer Support and Standard Community Services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- < 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Jewish Family Service
Los Angeles, California, 90010
University of Wisconsin
Madison, Wisconsin, 53705
Aliance For Children and Families
Milwaukee, Wisconsin, 53224
Community Place of Greater Rochester
Rochester, New York, 14609
Alpert Jewish Family and Children's Service
West Palm Beach, Florida, 33407
About this study
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:
- 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.
- 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.
Read the 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
- Conditions
- Wellness Programs, Hospitalization, Emergency Room
- Being tested
- Peer-to-Peer Support, Standard Community Services
- Keywords
- Older Adults, Aging in Place
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-to-Peer SupportBehavioural
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 ServicesBehavioural
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 group | Role | What they receive |
|---|---|---|
| Peer-to-peer support (non-randomized) | Experimental | 225 older adults that are currently receiving peer-to-peer support Receives: Behavioral: Peer-to-Peer Support |
| Standard Services (non-randomized) | Active comparator | 225 older adults will continue receiving standard community services Receives: Behavioral: Standard Community Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (10)
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.
Measured: 1 year
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
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wellness ProgramsStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Elizabeth A Jacobs, MD MPP, Principal investigator, UMadison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308696
- Sponsor's protocol ID
- 2014-1013
- Other IDs
- 000001
- Status last verified
- Sep 2019
- First submitted
- 2 Dec 2014
- Last updated
- 4 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Peer-to-Peer Community Support to Promote Aging in Place
- ClinicalTrials.gov ID
- NCT02308696
- Acronym / sponsor ID
- 2014-1013
- Conditions
- Wellness Programs, Hospitalization, Emergency Room
- Keywords
- Older Adults, Aging in Place
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- 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
- Study start
- Mar 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Posted 4 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer-to-peer support (non-randomized) | Experimental | Behavioral: Peer-to-Peer Support225 older adults that are currently receiving peer-to-peer support |
| Standard Services (non-randomized) | Active comparator | Behavioral: Standard Community Services225 older adults will continue receiving standard community services |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Overall
Key exclusion criteria (4 listed)
- < 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer-to-Peer SupportAll 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. | Behavioural | Peer-to-peer support (non-randomized) |
| Standard Community ServicesAll 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 | Behavioural | Standard Services (non-randomized) |
Primary outcome
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
10 secondary outcomes
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).
Time frame: 1 year
Depressive Symptoms as Assessed by the 10 Item Version of the Center of Epidemiologic Studies-Depression Scale
Time frame: 1 year
Anxiety Symptoms as Assessed by the 5-item Version of the Geriatric Anxiety Inventory Short Form
Time frame: 1 year
Loneliness as Assessed by the Short Scale for Measuring Loneliness in a Large Survey
Time frame: 1 year
Self-Efficacy as Assessed by the General Self-efficacy Scale to Measure an Individual's Sense of Perceived Self-efficacy.
Time frame: 1 year
Resilience as Assessed by the Brief Resilience Scale
Time frame: 1 year
Social Support as Assessed by the 8-item Medical Outcomes Study Social Support Survey
Time frame: 1 year
Mobility Disability as Assessed by the Rosow-Breslow Scale
Time frame: 1 year
Physical Health as Assessed by the NAGI Test
Time frame: 1 year
Medical Conditions as Assessed by the Medical Conditions Questionnaire (MCQ)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Wellness Programs
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruiting
Home-Based Respiratory Muscle Training and Aerobic Exercise Programs to Improve Lung Health in Current and Former Cigarette Smokers
Lung Carcinoma
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth A Jacobs, MD MPP principal investigator
UMadison
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-to-Peer Support and Standard Community Services in people with Wellness Programs and Hospitalization, run by University of Wisconsin, Madison at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Hospitalizations, Emergency Department Visits, and Urgent Care Visits (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.