A Community Health Worker Program to Support Rural Older Adults

Study Overview
=================
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.

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

Conditions
-----------------
Frail Elderly, Cognitive Impairment, Mobility Limitation, Depressive Symptoms

Intervention / Treatment
-----------------
* Behavioral: Tai Ji Quan: Moving for Better Balance
* Behavioral: Behavioral Activation
* Other: Resource Navigation
* Other: Enhanced Usual Care


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHW Intervention<br>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. | Behavioral: Tai Ji Quan: Moving for Better Balance<br>* 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.<br>Behavioral: Behavioral Activation<br>* 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.<br>Other: Resource Navigation<br>* 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.<br>|
| Active Comparator: Enhanced Usual Care<br>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. | Other: Enhanced Usual Care<br>* 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.<br>|

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 | 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) | 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) | 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 (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 | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Functional decline, Older adult, Community health workers, Cognitive impairment, Mobility limitation, Depressive symptoms, Rural, Primary care