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Completed

NCT Number: NCT03843333

A Community Health Worker Program to Support 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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maine Dartmouth Geriatric Medicine, Augusta, Maine, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tai Ji Quan: Moving for Better Balance

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

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

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

Other outcomes

  1. Change in handgrip strength

    Time frame: Baseline, 3, 6, and 9 months.

    Measured grip strength using a handheld Jamar dynamometer.

  2. Change in falls frequency.

    Time frame: Baseline, 3, 6, and 9 months.

    Self-reported number of falls in the past 3 months.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. Feasibility of recruitment

    Time frame: At recruitment completion, approximately 3 months.

    Ability to recruit n = 24 intervention and n = 24 comparison participants.

  16. Retention

    Time frame: At study completion, approximately 9 months.

    Percent of scheduled study assessment visits completed by participants.

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • Central Vermont Medical Center
  • Dartmouth College
  • Dartmouth SYNERGY Clinical and Translational Science Institute
  • Dartmouth-Hitchcock Medical Center
  • Maine-Dartmouth Family Medicine Residency
  • MaineGeneral Health
  • MaineHealth
  • Northern New England Clinical and Translational Research Network

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 18, 2019
Registry last updated
Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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