A Community Health Worker Program to Support Rural Older Adults

NCT ID: NCT03843333

Last Updated: 2020-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-10

Study Completion Date

2020-07-02

Brief Summary

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This study will investigate an intervention delivered by community health workers for older adults with signs of cognitive impairment, mobility loss, and depression in the rural primary care setting.

Detailed Description

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The population of the United States is aging rapidly, and the populations of Vermont (VT), New Hampshire (NH), and Maine (ME) are among the oldest in the nation. There is a need to develop and disseminate interventions to prevent functional decline in older adults, defined as difficulty completing daily activities independently. Cognitive impairment, depressive symptoms, and mobility loss are three common syndromes identified in primary care that contribute to functional decline in older adults. Evidence-based interventions can address early stages of these three conditions; however older adults in rural communities may have particular difficulty accessing interventions due to limited health and social services. Community health workers (CHWs) offer a potential strategy to address gaps in care and deliver interventions to vulnerable older adults in rural communities.

The overarching goal of this study is to conduct a pilot investigation of a CHW-delivered intervention to slow progression of functional decline among at-risk older adults. Using qualitative and quantitative methods, this pilot study will: 1) Evaluate whether a multicomponent intervention delivered by CHWs for rural older adults at risk for functional decline is feasible to deliver and acceptable to older adults and their primary care teams; and 2) Explore the effectiveness of combined Tai Ji Quan: Moving for Better Balance (TJQMBB), behavioral activation (BA), and resource navigation in slowing functional decline among older adults with co-occurring early impairments in cognition, mood, and mobility.

Older adults who are at high risk for functional decline will be recruited from partnering primary care sites (two intervention sites in VT and ME, and one comparison site in NH) based on results from the Medicare Annual Wellness Visit (AWV), which incorporates screening for cognitive impairment, depression, and falls risk, as well as provider referral and chart review. CHWs will be trained to deliver a 6-month intervention incorporating two evidence-based interventions that target cognition, depressive symptoms, and mobility (TJQMBB and behavioral activation), and resource navigation to address unmet social needs that may create barriers. Feasibility, acceptability, and potential effectiveness will be assessed through a combination of qualitative interviews, standardized questionnaires, physical measurements, and surveys.

Conditions

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Frail Elderly Cognitive Impairment Mobility Limitation Depressive Symptoms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

24 participants at two intervention sites (n = 12 participants per site) will be compared with 24 participants at an enhanced usual care comparison site. We will also conduct qualitative interviews with 16 clinical staff and community health workers.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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CHW Intervention

CHWs will deliver three intervention components (Tai Ji Quan: Moving for Better Balance, Behavioral Activation, and Resource Navigation) to all participants at intervention sites over a 6-month period.

Group Type EXPERIMENTAL

Tai Ji Quan: Moving for Better Balance

Intervention Type BEHAVIORAL

TJQMBB is an evidence-based, Centers for Disease Control and Prevention (CDC)-recommended, group falls prevention program based in Tai Chi that has been shown to reduce falls risk, improve physical function, and improve cognition. The program is delivered in 1-hour sessions twice weekly over 24 weeks, with the first 12 weeks spent learning the basic Tai Ji Quan forms and the second 12 weeks focused on variations in practice that progressively increase physical and cognitive demands. A physical therapist at Dartmouth is an authorized TJQMBB trainer and will train the CHWs to deliver the intervention and provide remote supervision monthly.

Behavioral Activation

Intervention Type BEHAVIORAL

BA is a brief intervention for depressive symptoms that focuses on engagement in positively-reinforcing activities and decreasing activity avoidance. CHWs will be trained by Dartmouth psychologists to deliver a brief behavioral activation program to encourage participants to increase their involvement in meaningful activities. BA will be delivered in one-hour sessions in the home every other week for 12 weeks. Supervision will be provided remotely on a weekly basis.

Resource Navigation

Intervention Type OTHER

CHWs will assess participants' unmet psychosocial needs and assist them in identifying and connecting them with resources to address these needs.Types of assistance may include identifying transportation services, assisting with applications for benefits, linking participants to Meals on Wheels and other local food resources, and connecting participants to community programs for older adults. We expect that participant needs and services delivered will vary and acknowledge that this intervention component will not be standardized due to the nature of this work.

Enhanced Usual Care

Comparison participants will receive a guide on community resources for older adults, and assistance from the research team in making initial connections to resources if desired.

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type OTHER

Comparison participants will receive a detailed resource guide on community supports for older adults. The research team will facilitate referrals to local resources (e.g. the Dartmouth Aging Resource Center) if desired by participants. Data from research assessments of cognition, depressive symptoms, mobility, and functional status will be provided to the primary care team for follow-up and intervention as needed.

Interventions

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Tai Ji Quan: Moving for Better Balance

TJQMBB is an evidence-based, Centers for Disease Control and Prevention (CDC)-recommended, group falls prevention program based in Tai Chi that has been shown to reduce falls risk, improve physical function, and improve cognition. The program is delivered in 1-hour sessions twice weekly over 24 weeks, with the first 12 weeks spent learning the basic Tai Ji Quan forms and the second 12 weeks focused on variations in practice that progressively increase physical and cognitive demands. A physical therapist at Dartmouth is an authorized TJQMBB trainer and will train the CHWs to deliver the intervention and provide remote supervision monthly.

Intervention Type BEHAVIORAL

Behavioral Activation

BA is a brief intervention for depressive symptoms that focuses on engagement in positively-reinforcing activities and decreasing activity avoidance. CHWs will be trained by Dartmouth psychologists to deliver a brief behavioral activation program to encourage participants to increase their involvement in meaningful activities. BA will be delivered in one-hour sessions in the home every other week for 12 weeks. Supervision will be provided remotely on a weekly basis.

Intervention Type BEHAVIORAL

Resource Navigation

CHWs will assess participants' unmet psychosocial needs and assist them in identifying and connecting them with resources to address these needs.Types of assistance may include identifying transportation services, assisting with applications for benefits, linking participants to Meals on Wheels and other local food resources, and connecting participants to community programs for older adults. We expect that participant needs and services delivered will vary and acknowledge that this intervention component will not be standardized due to the nature of this work.

Intervention Type OTHER

Enhanced Usual Care

Comparison participants will receive a detailed resource guide on community supports for older adults. The research team will facilitate referrals to local resources (e.g. the Dartmouth Aging Resource Center) if desired by participants. Data from research assessments of cognition, depressive symptoms, mobility, and functional status will be provided to the primary care team for follow-up and intervention as needed.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 65 or greater
* Positive for at least 2 of the following: 1) PHQ-2 score ≥2 or PHQ-9 score ≥5; 2) Mini-Cog score \<4 or MoCA score \<26 or Six-item screener with ≥2 errors; 3) "Yes" response to any of 3 falls risk screening questions or Timed Up and Go time 12 seconds or higher

Exclusion Criteria

* Active suicidal ideation
* PHQ-9 score \>14
* MoCA score \<19
* Inability to ambulate (use of an assistive device is acceptable)
* Inability to stand steadily in a stationary position without support
* Physician objection to participation due to medical, psychological, or other concerns
* Inability to speak and understand English
* Lack of capacity to provide informed consent as determined by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Vermont Medical Center

UNKNOWN

Sponsor Role collaborator

Dartmouth College

OTHER

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role collaborator

MaineHealth

OTHER

Sponsor Role collaborator

MaineGeneral Health

OTHER

Sponsor Role collaborator

Maine-Dartmouth Family Medicine Residency

UNKNOWN

Sponsor Role collaborator

Dartmouth SYNERGY Clinical and Translational Science Institute

UNKNOWN

Sponsor Role collaborator

Northern New England Clinical and Translational Research Network

UNKNOWN

Sponsor Role collaborator

University of Vermont

OTHER

Sponsor Role lead

Responsible Party

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Michael LaMantia

Section Head, Geriatric Medicine, Larner College of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael A LaMantia, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

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Maine Dartmouth Geriatric Medicine

Augusta, Maine, United States

Site Status

Dartmouth-Hitchcock Lyme

Lyme, New Hampshire, United States

Site Status

Integrative Family Medicine - Montpelier

Montpelier, Vermont, United States

Site Status

Countries

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United States

References

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Li F, Harmer P, Fisher KJ, McAuley E, Chaumeton N, Eckstrom E, Wilson NL. Tai Chi and fall reductions in older adults: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2005 Feb;60(2):187-94. doi: 10.1093/gerona/60.2.187.

Reference Type BACKGROUND
PMID: 15814861 (View on PubMed)

Li F, Harmer P, Liu Y, Chou LS. Tai Ji Quan and global cognitive function in older adults with cognitive impairment: a pilot study. Arch Gerontol Geriatr. 2014 May-Jun;58(3):434-9. doi: 10.1016/j.archger.2013.12.003. Epub 2013 Dec 22.

Reference Type BACKGROUND
PMID: 24398166 (View on PubMed)

Li F. Transforming traditional Tai Ji Quan techniques into integrative movement therapy-Tai Ji Quan: Moving for Better Balance. J Sport Health Sci. 2014 Mar 1;3(1):9-15. doi: 10.1016/j.jshs.2013.11.002.

Reference Type BACKGROUND
PMID: 25126445 (View on PubMed)

Orgeta V, Brede J, Livingston G. Behavioural activation for depression in older people: systematic review and meta-analysis. Br J Psychiatry. 2017 Nov;211(5):274-279. doi: 10.1192/bjp.bp.117.205021. Epub 2017 Oct 5.

Reference Type BACKGROUND
PMID: 28982660 (View on PubMed)

Lejuez CW, Hopko DR, Acierno R, Daughters SB, Pagoto SL. Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behav Modif. 2011 Mar;35(2):111-61. doi: 10.1177/0145445510390929.

Reference Type BACKGROUND
PMID: 21324944 (View on PubMed)

Rosenthal EL, Brownstein JN, Rush CH, Hirsch GR, Willaert AM, Scott JR, Holderby LR, Fox DJ. Community health workers: part of the solution. Health Aff (Millwood). 2010 Jul;29(7):1338-42. doi: 10.1377/hlthaff.2010.0081.

Reference Type BACKGROUND
PMID: 20606185 (View on PubMed)

Kim K, Choi JS, Choi E, Nieman CL, Joo JH, Lin FR, Gitlin LN, Han HR. Effects of Community-Based Health Worker Interventions to Improve Chronic Disease Management and Care Among Vulnerable Populations: A Systematic Review. Am J Public Health. 2016 Apr;106(4):e3-e28. doi: 10.2105/AJPH.2015.302987. Epub 2016 Feb 18.

Reference Type BACKGROUND
PMID: 26890177 (View on PubMed)

Barnett ML, Gonzalez A, Miranda J, Chavira DA, Lau AS. Mobilizing Community Health Workers to Address Mental Health Disparities for Underserved Populations: A Systematic Review. Adm Policy Ment Health. 2018 Mar;45(2):195-211. doi: 10.1007/s10488-017-0815-0.

Reference Type BACKGROUND
PMID: 28730278 (View on PubMed)

Related Links

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Other Identifiers

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18-0685

Identifier Type: -

Identifier Source: org_study_id

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