NCT03843333

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

June 10, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2020

Completed
Last Updated

October 1, 2020

Status Verified

September 1, 2020

Enrollment Period

11 months

First QC Date

February 7, 2019

Last Update Submit

September 30, 2020

Conditions

Keywords

Functional declineOlder adultCommunity health workersCognitive impairmentMobility limitationDepressive symptomsRuralPrimary care

Outcome Measures

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

    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 Outcomes (4)

  • Change in cognitive function as measured by the Montreal Cognitive Assessment (MoCA)

    Baseline, 3, 6, and 9 months.

  • Change in depressive symptom severity as measured by the Patient Health Questionnaire (PHQ-9)

    Baseline, 3, 6, and 9 months.

  • Change in mobility as measured by the Timed Up and Go (TUG)

    Baseline, 3, 6, and 9 months.

  • Change in mobility as measured by the 30-Second Chair Stand

    Baseline, 3, 6, and 9 months.

Other Outcomes (16)

  • Change in handgrip strength

    Baseline, 3, 6, and 9 months.

  • Change in falls frequency.

    Baseline, 3, 6, and 9 months.

  • Change in social support as measured by the Duke Social Support Index

    Baseline, 3, 6, and 9 months.

  • +13 more other outcomes

Study Arms (2)

CHW Intervention

EXPERIMENTAL

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 BalanceBehavioral: Behavioral ActivationOther: Resource Navigation

Enhanced Usual Care

ACTIVE COMPARATOR

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

Interventions

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.

CHW Intervention

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.

CHW Intervention

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.

CHW Intervention

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.

Enhanced Usual Care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Maine Dartmouth Geriatric Medicine

Augusta, Maine, 04330, United States

Location

Dartmouth-Hitchcock Lyme

Lyme, New Hampshire, 03768, United States

Location

Integrative Family Medicine - Montpelier

Montpelier, Vermont, 05602, United States

Location

Related Publications (8)

  • 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.

    PMID: 15814861BACKGROUND
  • 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.

    PMID: 24398166BACKGROUND
  • 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.

    PMID: 25126445BACKGROUND
  • 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.

    PMID: 28982660BACKGROUND
  • 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.

    PMID: 21324944BACKGROUND
  • 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.

    PMID: 20606185BACKGROUND
  • 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.

    PMID: 26890177BACKGROUND
  • 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.

    PMID: 28730278BACKGROUND

Related Links

MeSH Terms

Conditions

Cognitive DysfunctionMobility LimitationDepression

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Michael A LaMantia, MD, MPH

    University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Section Head, Geriatric Medicine, Larner College of Medicine

Study Record Dates

First Submitted

February 7, 2019

First Posted

February 18, 2019

Study Start

June 10, 2019

Primary Completion

April 28, 2020

Study Completion

July 2, 2020

Last Updated

October 1, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations