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A Community Health Worker Program to Support Rural Older Adults

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ClinicalTrials.gov Identifier: NCT03843333
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : June 7, 2019
Sponsor:
Collaborators:
Central Vermont Medical Center
Dartmouth College
Dartmouth-Hitchcock Medical Center
Maine Medical Center
MaineGeneral Health
Maine-Dartmouth Family Medicine Residency
Dartmouth SYNERGY Clinical and Translational Science Institute
Northern New England Clinical and Translational Research Network
Information provided by (Responsible Party):
Michael LaMantia, University of Vermont

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.

Condition or disease Intervention/treatment Phase
Frail Elderly Cognitive Impairment Mobility Limitation Depressive Symptoms Behavioral: Tai Ji Quan: Moving for Better Balance Behavioral: Behavioral Activation Other: Resource Navigation Other: Enhanced Usual Care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feasibility of a CHW Intervention for Functional Decline in Rural Older Adults
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

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.
Behavioral: 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.

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.

Other: 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.

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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03843333


Contacts
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Contact: Meaghan A Kennedy, MD, MPH 603-653-3463 meaghan.a.kennedy@hitchcock.org

Locations
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United States, Maine
Maine Dartmouth Geriatric Medicine Recruiting
Augusta, Maine, United States, 04330
Contact: Annette Beyea, DO, MPH    207-626-7400    Annette.Beyea@MaineGeneral.org   
Sub-Investigator: Annette Beyea, DO, MPH         
Sub-Investigator: Neil Korsen, MD, MSc         
United States, New Hampshire
Dartmouth-Hitchcock Lyme Recruiting
Lyme, New Hampshire, United States, 03768
Contact: Kenton Powell, MD    603-650-1070    Kenton.E.Powell@hitchcock.org   
Sub-Investigator: Kenton Powell, MD         
Sub-Investigator: John Batsis, MD         
United States, Vermont
Integrative Family Medicine - Montpelier Recruiting
Montpelier, Vermont, United States, 05602
Contact: Jeremiah Eckhaus, MD    802-223-4738    Jeremiah.Eckhaus@cvmc.org   
Sub-Investigator: Jeremiah Eckhaus, MD         
Sponsors and Collaborators
University of Vermont
Central Vermont Medical Center
Dartmouth College
Dartmouth-Hitchcock Medical Center
Maine Medical Center
MaineGeneral Health
Maine-Dartmouth Family Medicine Residency
Dartmouth SYNERGY Clinical and Translational Science Institute
Northern New England Clinical and Translational Research Network
Investigators
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Principal Investigator: Michael A LaMantia, MD, MPH University of Vermont

Additional Information:
Publications:

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Responsible Party: Michael LaMantia, Section Head, Geriatric Medicine, Larner College of Medicine, University of Vermont
ClinicalTrials.gov Identifier: NCT03843333     History of Changes
Other Study ID Numbers: 18-0685
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael LaMantia, University of Vermont:
Functional decline
Older adult
Community health workers
Cognitive impairment
Mobility limitation
Depressive symptoms
Rural
Primary care
Additional relevant MeSH terms:
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Mobility Limitation
Cognitive Dysfunction
Depression
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Behavioral Symptoms
Signs and Symptoms