A Community Health Worker Program to Support Rural Older Adults

September 30, 2020 updated by: Michael LaMantia, University of Vermont

Feasibility of a CHW Intervention for Functional Decline in Rural Older Adults

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maine
      • Augusta, Maine, United States, 04330
        • Maine Dartmouth Geriatric Medicine
    • New Hampshire
      • Lyme, New Hampshire, United States, 03768
        • Dartmouth-Hitchcock Lyme
    • Vermont
      • Montpelier, Vermont, United States, 05602
        • Integrative Family Medicine - Montpelier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in functional status from as measured by the Complete Activities of Daily Living Section of the Older Americans' Resources and Services (OARS) Multidimensional Functional Assessment Questionnaire
Time Frame: Baseline, 3, 6, and 9 months.
A 14-item self-report measure of independence in performing Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs). Scores range from 0-28 with a score of 0 indicating complete dependence in activities and 28 indicating complete independence. ADL and IADL subscales each have 7 items scored from 0-14 which are summed to calculate the total score.
Baseline, 3, 6, and 9 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cognitive function as measured by the Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline, 3, 6, and 9 months.
A brief interviewer-delivered cognitive assessment that assesses visuospatial/executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. Scores range from 0-30 with a high score of 26-30 indicating normal cognitive function.
Baseline, 3, 6, and 9 months.
Change in depressive symptom severity as measured by the Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline, 3, 6, and 9 months.
A 9-item self-report measure of severity of depressive symptoms. Scores range from 0-27 with 0-4 indicating no or minimal depression, 5-9 indicating mild depression, 10-14 indicating moderate depression, 15-19 indicating moderately severe depression, and 20-27 indicating severe depression.
Baseline, 3, 6, and 9 months.
Change in mobility as measured by the Timed Up and Go (TUG)
Time Frame: Baseline, 3, 6, and 9 months.
Time (in seconds) to rise from a chair, walk 10 feet, and return to seated position in chair. A time of 12 seconds of higher indicates falls risk.
Baseline, 3, 6, and 9 months.
Change in mobility as measured by the 30-Second Chair Stand
Time Frame: Baseline, 3, 6, and 9 months.
Number of times participant is able to rise to a standing position from a chair in 30 seconds. Age and gender-specific cutoffs are used to determine falls risk (e.g. scores less than 12 for men and less than 11 for women are considered abnormal for age 65-69).
Baseline, 3, 6, and 9 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in handgrip strength
Time Frame: Baseline, 3, 6, and 9 months.
Measured grip strength using a handheld Jamar dynamometer.
Baseline, 3, 6, and 9 months.
Change in falls frequency.
Time Frame: Baseline, 3, 6, and 9 months.
Self-reported number of falls in the past 3 months.
Baseline, 3, 6, and 9 months.
Change in social support as measured by the Duke Social Support Index
Time Frame: Baseline, 3, 6, and 9 months.
11-item self-report measure of social support for the elderly, with scores ranging from 11-33 (low social support to high social support). Social Interaction (range 4-12) and Subjective Social Support (range 7-21) subscales are totaled for the overall score.
Baseline, 3, 6, and 9 months.
Change in self-reported general health status as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2.
Time Frame: Baseline, 3, 6, and 9 months.
10-item self-report measure of global physical and mental health status. Raw summed scores of 4-20 (higher scores indicates better functioning) for physical and mental health subscales are converted to standardized T-scores each with a mean of 50.
Baseline, 3, 6, and 9 months.
Number and type of social needs and community resources used as measured by a checklist
Time Frame: Baseline, 3, 6, and 9 months.
Brief checklist to assess psychosocial needs (e.g. financial concerns, transportation problems, food insecurity) and types of community resources used in the past 3 months.
Baseline, 3, 6, and 9 months.
Health care utilization as measured by past 3 month Emergency Department (ED) visits
Time Frame: Baseline, 3, 6, and 9 months.
Number of ED visits in the past 3 months.
Baseline, 3, 6, and 9 months.
Health care utilization as measured by past 3 month hospitalizations
Time Frame: Baseline, 3, 6, and 9 months.
Number of hospitalizations in the past 3 months.
Baseline, 3, 6, and 9 months.
Health care utilization as measured by past 3 month long-term care placements
Time Frame: Baseline, 3, 6, and 9 months.
Number of long-term care placements in the past 3 months.
Baseline, 3, 6, and 9 months.
Feasibility and acceptability as determined by qualitative interviews
Time Frame: At completion of study, approximately 9 months.
Semi-structured interviews will be conducted with participants, clinical staff, and CHWs and will undergo thematic analysis.
At completion of study, approximately 9 months.
Fidelity of TJQMBB as measured by fidelity checklist
Time Frame: At completion of TJQMBB phase of intervention, approximately 6 months.
Percent of intervention sessions with fidelity based on checklist of required components.
At completion of TJQMBB phase of intervention, approximately 6 months.
Fidelity of BA as measured by fidelity checklist
Time Frame: At completion of BA phase of intervention, approximately 3 months
Percent of intervention sessions with fidelity based on checklist of required components.
At completion of BA phase of intervention, approximately 3 months
Acceptability of the intervention as measured by satisfaction survey
Time Frame: At completion of intervention phase, approximately 6 months.
Percent of participant satisfaction surveys with positive ratings.
At completion of intervention phase, approximately 6 months.
Acceptability of intervention as measured by completion of TJQMBB sessions
Time Frame: At completion of TJQMBB phase of intervention, approximately 6 months.
Percent of scheduled TJQMBB sessions attended by participants.
At completion of TJQMBB phase of intervention, approximately 6 months.
Acceptability of intervention as measured by completion of BA sessions
Time Frame: At completion of BA phase of intervention, approximately 3 months.
Percent of scheduled BA sessions completed by participants.
At completion of BA phase of intervention, approximately 3 months.
Feasibility of recruitment
Time Frame: At recruitment completion, approximately 3 months.
Ability to recruit n = 24 intervention and n = 24 comparison participants.
At recruitment completion, approximately 3 months.
Retention
Time Frame: At study completion, approximately 9 months.
Percent of scheduled study assessment visits completed by participants.
At study completion, approximately 9 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2019

Primary Completion (Actual)

April 28, 2020

Study Completion (Actual)

July 2, 2020

Study Registration Dates

First Submitted

February 7, 2019

First Submitted That Met QC Criteria

February 12, 2019

First Posted (Actual)

February 18, 2019

Study Record Updates

Last Update Posted (Actual)

October 1, 2020

Last Update Submitted That Met QC Criteria

September 30, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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