A Community Health Worker Program to Support Rural Older Adults
Primary Purpose
Frail Elderly, Cognitive Impairment, Mobility Limitation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tai Ji Quan: Moving for Better Balance
Behavioral Activation
Resource Navigation
Enhanced Usual Care
Sponsored by
About this trial
This is an interventional prevention trial for Frail Elderly focused on measuring Functional decline, Older adult, Community health workers, Cognitive impairment, Mobility limitation, Depressive symptoms, Rural, Primary care
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)
Sites / Locations
- Maine Dartmouth Geriatric Medicine
- Dartmouth-Hitchcock Lyme
- Integrative Family Medicine - Montpelier
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CHW Intervention
Enhanced Usual Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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).
Full Information
NCT ID
NCT03843333
First Posted
February 7, 2019
Last Updated
September 30, 2020
Sponsor
University of Vermont
Collaborators
Central Vermont Medical Center, Dartmouth College, Dartmouth-Hitchcock Medical Center, MaineHealth, MaineGeneral Health, Maine-Dartmouth Family Medicine Residency, Dartmouth SYNERGY Clinical and Translational Science Institute, Northern New England Clinical and Translational Research Network
1. Study Identification
Unique Protocol Identification Number
NCT03843333
Brief Title
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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 10, 2019 (Actual)
Primary Completion Date
April 28, 2020 (Actual)
Study Completion Date
July 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
Central Vermont Medical Center, Dartmouth College, Dartmouth-Hitchcock Medical Center, MaineHealth, MaineGeneral Health, Maine-Dartmouth Family Medicine Residency, Dartmouth SYNERGY Clinical and Translational Science Institute, Northern New England Clinical and Translational Research Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CHW Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tai Ji Quan: Moving for Better Balance
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Resource Navigation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Enhanced Usual Care
Intervention Description
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 Measure Information:
Title
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
Description
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.
Time Frame
Baseline, 3, 6, and 9 months.
Secondary Outcome Measure Information:
Title
Change in cognitive function as measured by the Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
Baseline, 3, 6, and 9 months.
Title
Change in depressive symptom severity as measured by the Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
Baseline, 3, 6, and 9 months.
Title
Change in mobility as measured by the Timed Up and Go (TUG)
Description
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.
Time Frame
Baseline, 3, 6, and 9 months.
Title
Change in mobility as measured by the 30-Second Chair Stand
Description
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).
Time Frame
Baseline, 3, 6, and 9 months.
Other Pre-specified Outcome Measures:
Title
Change in handgrip strength
Description
Measured grip strength using a handheld Jamar dynamometer.
Time Frame
Baseline, 3, 6, and 9 months.
Title
Change in falls frequency.
Description
Self-reported number of falls in the past 3 months.
Time Frame
Baseline, 3, 6, and 9 months.
Title
Change in social support as measured by the Duke Social Support Index
Description
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.
Time Frame
Baseline, 3, 6, and 9 months.
Title
Change in self-reported general health status as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2.
Description
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.
Time Frame
Baseline, 3, 6, and 9 months.
Title
Number and type of social needs and community resources used as measured by a checklist
Description
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.
Time Frame
Baseline, 3, 6, and 9 months.
Title
Health care utilization as measured by past 3 month Emergency Department (ED) visits
Description
Number of ED visits in the past 3 months.
Time Frame
Baseline, 3, 6, and 9 months.
Title
Health care utilization as measured by past 3 month hospitalizations
Description
Number of hospitalizations in the past 3 months.
Time Frame
Baseline, 3, 6, and 9 months.
Title
Health care utilization as measured by past 3 month long-term care placements
Description
Number of long-term care placements in the past 3 months.
Time Frame
Baseline, 3, 6, and 9 months.
Title
Feasibility and acceptability as determined by qualitative interviews
Description
Semi-structured interviews will be conducted with participants, clinical staff, and CHWs and will undergo thematic analysis.
Time Frame
At completion of study, approximately 9 months.
Title
Fidelity of TJQMBB as measured by fidelity checklist
Description
Percent of intervention sessions with fidelity based on checklist of required components.
Time Frame
At completion of TJQMBB phase of intervention, approximately 6 months.
Title
Fidelity of BA as measured by fidelity checklist
Description
Percent of intervention sessions with fidelity based on checklist of required components.
Time Frame
At completion of BA phase of intervention, approximately 3 months
Title
Acceptability of the intervention as measured by satisfaction survey
Description
Percent of participant satisfaction surveys with positive ratings.
Time Frame
At completion of intervention phase, approximately 6 months.
Title
Acceptability of intervention as measured by completion of TJQMBB sessions
Description
Percent of scheduled TJQMBB sessions attended by participants.
Time Frame
At completion of TJQMBB phase of intervention, approximately 6 months.
Title
Acceptability of intervention as measured by completion of BA sessions
Description
Percent of scheduled BA sessions completed by participants.
Time Frame
At completion of BA phase of intervention, approximately 3 months.
Title
Feasibility of recruitment
Description
Ability to recruit n = 24 intervention and n = 24 comparison participants.
Time Frame
At recruitment completion, approximately 3 months.
Title
Retention
Description
Percent of scheduled study assessment visits completed by participants.
Time Frame
At study completion, approximately 9 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A LaMantia, MD, MPH
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maine Dartmouth Geriatric Medicine
City
Augusta
State/Province
Maine
ZIP/Postal Code
04330
Country
United States
Facility Name
Dartmouth-Hitchcock Lyme
City
Lyme
State/Province
New Hampshire
ZIP/Postal Code
03768
Country
United States
Facility Name
Integrative Family Medicine - Montpelier
City
Montpelier
State/Province
Vermont
ZIP/Postal Code
05602
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15814861
Citation
Li F, Harmer P, Fisher KJ, McAuley E, Chaumeton N, Eckstrom E, Wilson NL. Tai Chi and fall reductions in older adults: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2005 Feb;60(2):187-94. doi: 10.1093/gerona/60.2.187.
Results Reference
background
PubMed Identifier
24398166
Citation
Li F, Harmer P, Liu Y, Chou LS. Tai Ji Quan and global cognitive function in older adults with cognitive impairment: a pilot study. Arch Gerontol Geriatr. 2014 May-Jun;58(3):434-9. doi: 10.1016/j.archger.2013.12.003. Epub 2013 Dec 22.
Results Reference
background
PubMed Identifier
25126445
Citation
Li F. Transforming traditional Tai Ji Quan techniques into integrative movement therapy-Tai Ji Quan: Moving for Better Balance. J Sport Health Sci. 2014 Mar 1;3(1):9-15. doi: 10.1016/j.jshs.2013.11.002.
Results Reference
background
PubMed Identifier
28982660
Citation
Orgeta V, Brede J, Livingston G. Behavioural activation for depression in older people: systematic review and meta-analysis. Br J Psychiatry. 2017 Nov;211(5):274-279. doi: 10.1192/bjp.bp.117.205021. Epub 2017 Oct 5.
Results Reference
background
PubMed Identifier
21324944
Citation
Lejuez CW, Hopko DR, Acierno R, Daughters SB, Pagoto SL. Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behav Modif. 2011 Mar;35(2):111-61. doi: 10.1177/0145445510390929.
Results Reference
background
PubMed Identifier
20606185
Citation
Rosenthal EL, Brownstein JN, Rush CH, Hirsch GR, Willaert AM, Scott JR, Holderby LR, Fox DJ. Community health workers: part of the solution. Health Aff (Millwood). 2010 Jul;29(7):1338-42. doi: 10.1377/hlthaff.2010.0081.
Results Reference
background
PubMed Identifier
26890177
Citation
Kim K, Choi JS, Choi E, Nieman CL, Joo JH, Lin FR, Gitlin LN, Han HR. Effects of Community-Based Health Worker Interventions to Improve Chronic Disease Management and Care Among Vulnerable Populations: A Systematic Review. Am J Public Health. 2016 Apr;106(4):e3-e28. doi: 10.2105/AJPH.2015.302987. Epub 2016 Feb 18.
Results Reference
background
PubMed Identifier
28730278
Citation
Barnett ML, Gonzalez A, Miranda J, Chavira DA, Lau AS. Mobilizing Community Health Workers to Address Mental Health Disparities for Underserved Populations: A Systematic Review. Adm Policy Ment Health. 2018 Mar;45(2):195-211. doi: 10.1007/s10488-017-0815-0.
Results Reference
background
Links:
URL
https://www.apha.org/policies-and-advocacy/public-health-policy-statements/policy-database/2014/07/09/14/19/support-for-community-health-workers-to-increase-health-access-and-to-reduce-health-inequities
Description
American Public Health Association Policy Statement on Community Health Workers
URL
https://tjqmbb.org/
Description
Web site for Tai Ji Quan: Moving for Better Balance program
Learn more about this trial
A Community Health Worker Program to Support Rural Older Adults
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