Frail ElderlyNCT03843333
A Community Health Worker Program to Support Rural Older Adults
A study testing Tai Ji Quan: Moving for Better Balance, Behavioral Activation and Resource Navigation in people with Frail Elderly and Cognitive Impairment, run by University of Vermont at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly, Cognitive Impairment, Mobility Limitation
- What is being tested?
- Tai Ji Quan: Moving for Better Balance, Behavioral Activation and Resource Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Jun 2019to 2 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Maine Dartmouth Geriatric Medicine
Augusta, Maine, 04330
Dartmouth-Hitchcock Lyme
Lyme, New Hampshire, 03768
Integrative Family Medicine - Montpelier
Montpelier, Vermont, 05602
About this study
Official title: Feasibility of a CHW Intervention for Functional Decline in 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.
Read the 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.
- Being tested
- Tai Ji Quan: Moving for Better Balance, Behavioral Activation, Resource Navigation, Enhanced Usual Care
- Keywords
- Functional decline, Older adult, Community health workers, Cognitive impairment, Mobility limitation, Depressive symptoms, Rural, Primary care
- Medical subject headings
- Cognitive Dysfunction, Mobility Limitation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Ji Quan: Moving for Better BalanceBehavioural
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 ActivationBehavioural
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 NavigationOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Tai Ji Quan: Moving for Better Balance; Behavioral: Behavioral Activation; Other: 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. Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3, 6, and 9 months.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, 3, 6, and 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start10 Jun 2019
- Primary completion28 Apr 2020
- Study completion2 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Frail ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Michael LaMantia, University of Vermont
- Investigators
- Michael A LaMantia, MD, MPH, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843333
- Sponsor's protocol ID
- 18-0685
- Status last verified
- Sep 2020
- First submitted
- 7 Feb 2019
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15814861Li 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.
PubMed 24398166Li 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.
PubMed 25126445Orgeta 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.
PubMed 28982660Lejuez 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.
PubMed 21324944Rosenthal 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.
PubMed 20606185Kim 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.
PubMed 26890177Barnett 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.
PubMed 28730278
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a CHW Intervention for Functional Decline in Rural Older Adults
- ClinicalTrials.gov ID
- NCT03843333
- Acronym / sponsor ID
- 18-0685
- Keywords
- Functional decline, Older adult, Community health workers, Cognitive impairment, Mobility limitation, Depressive symptoms, Rural, Primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- 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
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 28 Apr 2020 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CHW Intervention | Experimental | Behavioral: Tai Ji Quan: Moving for Better Balance, Behavioral: Behavioral Activation, Other: Resource NavigationCHWs 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. |
| Enhanced Usual Care | Active comparator | Other: Enhanced Usual CareComparison 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Ji Quan: Moving for Better BalanceTJQMBB 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. | Behavioural | CHW Intervention |
| Behavioral ActivationBA 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. | Behavioural | CHW Intervention |
| Resource NavigationCHWs 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. | Other | CHW Intervention |
| Enhanced Usual CareComparison 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. | Other | Enhanced Usual Care |
Primary outcome
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.
4 secondary outcomes
Change in cognitive function as measured by the Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, 3, 6, and 9 months.
Change in depressive symptom severity as measured by the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 3, 6, and 9 months.
Change in mobility as measured by the Timed Up and Go (TUG)
Time frame: Baseline, 3, 6, and 9 months.
Change in mobility as measured by the 30-Second Chair Stand
Time frame: Baseline, 3, 6, and 9 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Background: PubMed 15814861Li 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.
- Background: PubMed 24398166Li 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.
- Background: PubMed 25126445Li 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.
- Background: PubMed 28982660Orgeta 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.
- Background: PubMed 21324944Lejuez 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.
- Background: PubMed 20606185Rosenthal 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.
- Background: PubMed 26890177Kim 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.
- Background: PubMed 28730278Barnett 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.
- American Public Health Association Policy Statement on Community Health WorkersLink provided by the sponsor.
- Web site for Tai Ji Quan: Moving for Better Balance programLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A LaMantia, MD, MPH principal investigator
University of Vermont
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Ji Quan: Moving for Better Balance, Behavioral Activation and Resource Navigation in people with Frail Elderly and Cognitive Impairment, run by University of Vermont at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03843333, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.