Clinical trial NCT03843333: A Community Health Worker Program to Support Rural Older Adults
Official title: Feasibility of a CHW Intervention for Functional Decline in Rural Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly
Cognitive Impairment
Mobility Limitation
Depressive Symptoms
Keywords: Functional decline
Older adult
Community health workers
Cognitive impairment
Mobility limitation
Depressive symptoms
Rural
Primary care
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: Central Vermont Medical Center
name: Dartmouth College
name: Dartmouth-Hitchcock Medical Center
name: MaineHealth
name: MaineGeneral Health
name: Maine-Dartmouth Family Medicine Residency
name: Dartmouth SYNERGY Clinical and Translational Science Institute
name: Northern New England Clinical and Translational Research Network
First posted: 2019-02-18
Enrollment: 39
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: Baseline, 3, 6, and 9 months.
Secondary outcomes:
measure: Change in cognitive function as measured by the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, 3, 6, and 9 months.
measure: Change in depressive symptom severity as measured by the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 3, 6, and 9 months.
measure: Change in mobility as measured by the Timed Up and Go (TUG)
timeFrame: Baseline, 3, 6, and 9 months.
measure: Change in mobility as measured by the 30-Second Chair Stand
timeFrame: Baseline, 3, 6, and 9 months.
Other outcomes:
measure: Change in handgrip strength
timeFrame: Baseline, 3, 6, and 9 months.
measure: Change in falls frequency.
timeFrame: Baseline, 3, 6, and 9 months.
measure: Change in social support as measured by the Duke Social Support Index
timeFrame: Baseline, 3, 6, and 9 months.
measure: Change in self-reported general health status as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2.
timeFrame: Baseline, 3, 6, and 9 months.
measure: Number and type of social needs and community resources used as measured by a checklist
timeFrame: Baseline, 3, 6, and 9 months.
measure: Health care utilization as measured by past 3 month Emergency Department (ED) visits
timeFrame: Baseline, 3, 6, and 9 months.
measure: Health care utilization as measured by past 3 month hospitalizations
timeFrame: Baseline, 3, 6, and 9 months.
measure: Health care utilization as measured by past 3 month long-term care placements
timeFrame: Baseline, 3, 6, and 9 months.
measure: Feasibility and acceptability as determined by qualitative interviews
timeFrame: At completion of study, approximately 9 months.
measure: Fidelity of TJQMBB as measured by fidelity checklist
timeFrame: At completion of TJQMBB phase of intervention, approximately 6 months.
measure: Fidelity of BA as measured by fidelity checklist
timeFrame: At completion of BA phase of intervention, approximately 3 months
measure: Acceptability of the intervention as measured by satisfaction survey
timeFrame: At completion of intervention phase, approximately 6 months.
measure: Acceptability of intervention as measured by completion of TJQMBB sessions
timeFrame: At completion of TJQMBB phase of intervention, approximately 6 months.
measure: Acceptability of intervention as measured by completion of BA sessions
timeFrame: At completion of BA phase of intervention, approximately 3 months.
measure: Feasibility of recruitment
timeFrame: At recruitment completion, approximately 3 months.
measure: Retention
timeFrame: At study completion, approximately 9 months.
Locations:
city: Augusta
country: United States
facility: Maine Dartmouth Geriatric Medicine
state: Maine
city: Lyme
country: United States
facility: Dartmouth-Hitchcock Lyme
state: New Hampshire
city: Montpelier
country: United States
facility: Integrative Family Medicine - Montpelier
state: Vermont
Study officials:
affiliation: University of Vermont
name: Michael A LaMantia, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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