Frail Elderly SyndromeFPPNCT03585972
Frailty Prevention Program to Prevent Frailty Among Older African Americans
A study testing Frailty Prevention Program in people with Frail Elderly Syndrome, run by Wayne State University at 1 site in United States.
Trial summary
Between 20-60% of older adults experience frailty as they age. Frailty is a clinical state of increased vulnerability resulting from aging-associated declines in biological reserve across multiple physiologic systems. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- Frailty Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2018to 28 May 2019
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prefrail (meeting 1-2 of the following 5 criteria: self-report of loss of at least 10% of body weight over a 2-year period and the four following questions: (1) "Because of health problems, do you have any difficulty with lifting or carrying weights over 10 pounds, like a heavy bag of groceries?", (2) "Because of a health problem, do you have any difficulty with getting up from a chair after sitting for long periods?", (3) "Have you had any of the following persistent or troublesome problems: severe fatigue or exhaustion?", and (4) "Have you fallen down in the past 2 years?" )
- African American
- Age 55 and older
Who cannot join
- Moderate to severe dementia
- A serious physical disability that requires a caregiver to provide care for basic activities of daily living
- A terminal illness (e.g., end stage renal disease or end stage cancer).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Occupational Therapy Services to Improve Frailty Status
Between 20-60% of older adults experience frailty as they age. Frailty is a clinical state of increased vulnerability resulting from aging-associated declines in biological reserve across multiple physiologic systems. Because of the lack of biological reserve, relatively minor physical or psychological assaults have the potential to trigger a cascade of negative sequelae for frail older adults resulting in adverse health outcomes including mortality, disability in basic and instrumental activities of daily living, hospitalization and emergency visits, and institutionalization in community-dwelling older adults. Despite the potential personal and economic consequences of frailty syndrome, frailty is not an irreversible process. For example, a 4.5-year longitudinal study conducted by Gill et al., (2006) demonstrated that of their 754 community dwelling older adults, 58% had at least one change in frailty status during the study period and that approximately one third of these transitions were from a state of greater frailty to one of lesser frailty, suggesting that it is possible to reverse the frailty trajectory. Nonetheless, there is a lack effective means of reversing frailty or slowing the progression of older adults along the frailty continuum.The purpose of the proposed research is to evaluate the feasibility and preliminary effectiveness of an occupational therapy intervention delivered through the primary care setting for improving frailty status and physical functioning among older adults ages 55 and older who are pre-frail when compared to usual care.
Read the detailed description
Between 20-60% of older adults experience frailty as they age. Frailty is a clinical state of increased vulnerability resulting from aging-associated declines in biological reserve across multiple physiologic systems. Because of the lack of biological reserve, relatively minor physical or psychological assaults have the potential to trigger a cascade of negative sequelae for frail older adults resulting in adverse health outcomes including mortality, disability in basic and instrumental activities of daily living, mobility impairment, falls, hospitalization and emergency visits, and institutionalization in community-dwelling older adults. In addition, frailty results in increased healthcare cost and service utilization across both acute and community settings. Frail older adults (OA) have a higher frequency of primary care visits, consume 50% of all hospital care, use over 80% of home care services, and occupying 90% of all nursing home beds in the United States.
Despite the potential personal and economic consequences of frailty syndrome, frailty is not an irreversible process. For example, a 4.5-year longitudinal study conducted by Gill et al., (2006) demonstrated that of their 754 community dwelling older adults, 58% had at least one change in frailty status during the study period and that approximately one third of these transitions were from a state of greater frailty to one of lesser frailty, suggesting that it is possible to reverse the frailty trajectory. Nonetheless, there is a continued lack effective means of reversing frailty or slowing the progression of older adults along the frailty continuum. Interventions have been developed to slow or reverse frailty and have typically focused on exercise training, nutritional supplementation, pharmaceutical agents, or some combination of those elements. The efficacy of such interventions has been mixed with intensive physical activity interventions demonstrating the most promise. Yet intensive physical activity interventions are difficult to disseminate at a population level, and evidence suggests that even when participants experience a change in their frailty status as a result of intensive exercise intervention, they generally return to their pre-intervention state once exercise training is discontinued. Because of the lack knowledge about how best to address the problem of frailty in older adulthood, researchers have argued that the continued development and evaluation of interventions designed to prevent frailty or ameliorate the consequences of frailty should remain a top priority in aging research.
One approach that holds promise for preventing or slowing the progression of frailty is early identification of pre-frail individuals in the outpatient setting and referring them to occupational therapy services before individuals require more intensive inpatient services. Primary care geriatric clinics afford a unique opportunity for early identification and referral of at risk older adults during the course of routine care. Providers are often times more familiar with their patients, have had the opportunity to track their patient's progress over time, and therefore, are uniquely situated to identify changes in functional or health status and make appropriate referrals on behalf of their patients. While occupational therapists have not traditionally provided services in the primary care setting, occupational therapy services delivered in hospital, home, and community settings improve function and reduce healthcare costs among older adults. Occupational therapy services delivered in the primary care setting offers a unique opportunity to improve the health, function and wellbeing of frail, pre-frail, and at risk older adults (OA).
The purpose of the proposed research is to evaluate the feasibility and preliminary effectiveness of an occupational therapy intervention delivered through the primary care setting for improving frailty status and physical functioning among older adults (OA) ages 55 and older who are pre-frail when compared to usual care. Secondary aims include conducting exploratory analyses to examine potential mechanisms that may explain the intervention's effects, and evaluating the intervention's impact on secondary outcomes including occupational performance, quality of life, and care utilization.
The investigators hypothesize that occupational therapy services will result in greater improvement in the primary outcomes of frailty status (measured via the Fried Frailty criteria), physical function, and the secondary outcomes of occupational performance, health status (measured via weight and blood pressure), and care utilization (assessed via structured questionnaire) Quality of Life among the treatment group compared to usual care. The two specific aims of the study are:
- To evaluate intervention feasibility and acceptability. Determine if the occupational therapy services delivered are feasible and acceptable. By tracking time, effort, costs, adherence to recommendations, participant recruitment and retention rates, and intervention satisfaction among a sample of 150 pre-frail older adults, we expect to be able to provide data that both support the feasibility of the intervention and help us improve it for a subsequent study.
- To conduct a pilot randomized trial of the intervention components with 150 older adults to evaluate the impact of the occupational therapy intervention on the primary outcomes of frailty status and physical functioning, and the secondary outcomes of occupational performance, health status, quality of life and care usage. Hypotheses: Frailty status and physical functioning will be significantly improved following the intervention and will be maintained for 6-months after treatment termination.
- Conditions
- Frail Elderly Syndrome
- Being tested
- Frailty Prevention Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty Prevention ProgramBehavioural
4 face-to-face sessions, with a occupational therapist over 4 months to address function, safety, social participation, diet, exercise, sleep, and medication management. Sessions are expected to last between 60-120 minutes. The first session is a comprehensive occupational therapy evaluation and treatment plan. Sessions 2 and 3 involved physical activity and dietary education, counseling and goal setting. Session 4 involves reviewing program progress, and setting maintenance goals.
| Study group | Role | What they receive |
|---|---|---|
| Frailty Prevention Program | Experimental | 4 face-to-face sessions, with a licensed and registered occupational therapist over 4 months Receives: Behavioral: Frailty Prevention Program |
| Educational materials | No intervention | Participants receive publicly available educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Habit formation
Self-reported Behavioral Automaticity index
Measured: from week 0 to week 4
Frailty
Fried Frailty Index
Measured: From week 0 to week 16
Secondary outcomes (4)
Self Rate Quality of Life
WHOQOL BREF (brief version)
Measured: From week 0 to week 16
Social Participation
NIH PROMISE Ability to Participate \& Satisfaction with Social Roles (Short forms 8a)
Measured: From week 0 to week 16
Global Health
NIH PROMISE Global Health form
Measured: From week 0 to week 16
Health Service Utilization
Narrative self-report of services
Measured: From week 0 to week 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start5 May 2018
- Primary completion28 May 2019
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan Health Endowment Fund
- Responsible party
- Principal investigator, Heather Fritz, Wayne State University
- Investigators
- Heather Fritz, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585972
- Sponsor's protocol ID
- 1701000204
- Acronym
- FPP
- Status last verified
- Aug 2019
- First submitted
- 2 Jul 2018
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Therapy Services to Improve Frailty Status
- ClinicalTrials.gov ID
- NCT03585972
- Acronym / sponsor ID
- FPP / 1701000204
- Conditions
- Frail Elderly Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- Michigan Health Endowment Fund
- Study start
- 5 May 2018 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 13 Jul 2018 (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.
Between 20-60% of older adults experience frailty as they age. Frailty is a clinical state of increased vulnerability resulting from aging-associated declines in biological reserve across multiple physiologic systems. Because of the lack of biological reserve, relatively minor physical or psychological assaults have the potential to trigger a cascade of negative sequelae for frail older adults resulting in adverse health outcomes including mortality, disability in basic and instrumental activities of daily living, hospitalization and emergency visits, and institutionalization in community-dwelling older adults. Despite the potential personal and economic consequences of frailty syndrome, frailty is not an irreversible process. For example, a 4.5-year longitudinal study conducted by Gill et al., (2006) demonstrated that of their 754 community dwelling older adults, 58% had at least one change in frailty status during the study period and that approximately one third of these transitions were from a state of greater frailty to one of lesser frailty, suggesting that it is possible to reverse the frailty trajectory. Nonetheless, there is a lack effective means of reversing frailty or slowing the progression of older adults along the frailty continuum.The purpose of the proposed research is to evaluate the feasibility and preliminary effectiveness of an occupational therapy intervention delivered through the primary care setting for improving frailty status and physical functioning among older adults ages 55 and older who are pre-frail when compared to usual care.
Detailed description
Between 20-60% of older adults experience frailty as they age. Frailty is a clinical state of increased vulnerability resulting from aging-associated declines in biological reserve across multiple physiologic systems. Because of the lack of biological reserve, relatively minor physical or psychological assaults have the potential to trigger a cascade of negative sequelae for frail older adults resulting in adverse health outcomes including mortality, disability in basic and instrumental activities of daily living, mobility impairment, falls, hospitalization and emergency visits, and institutionalization in community-dwelling older adults. In addition, frailty results in increased healthcare cost and service utilization across both acute and community settings. Frail older adults (OA) have a higher frequency of primary care visits, consume 50% of all hospital care, use over 80% of home care services, and occupying 90% of all nursing home beds in the United States.
Despite the potential personal and economic consequences of frailty syndrome, frailty is not an irreversible process. For example, a 4.5-year longitudinal study conducted by Gill et al., (2006) demonstrated that of their 754 community dwelling older adults, 58% had at least one change in frailty status during the study period and that approximately one third of these transitions were from a state of greater frailty to one of lesser frailty, suggesting that it is possible to reverse the frailty trajectory. Nonetheless, there is a continued lack effective means of reversing frailty or slowing the progression of older adults along the frailty continuum. Interventions have been developed to slow or reverse frailty and have typically focused on exercise training, nutritional supplementation, pharmaceutical agents, or some combination of those elements. The efficacy of such interventions has been mixed with intensive physical activity interventions demonstrating the most promise. Yet intensive physical activity interventions are difficult to disseminate at a population level, and evidence suggests that even when participants experience a change in their frailty status as a result of intensive exercise intervention, they generally return to their pre-intervention state once exercise training is discontinued. Because of the lack knowledge about how best to address the problem of frailty in older adulthood, researchers have argued that the continued development and evaluation of interventions designed to prevent frailty or ameliorate the consequences of frailty should remain a top priority in aging research.
One approach that holds promise for preventing or slowing the progression of frailty is early identification of pre-frail individuals in the outpatient setting and referring them to occupational therapy services before individuals require more intensive inpatient services. Primary care geriatric clinics afford a unique opportunity for early identification and referral of at risk older adults during the course of routine care. Providers are often times more familiar with their patients, have had the opportunity to track their patient's progress over time, and therefore, are uniquely situated to identify changes in functional or health status and make appropriate referrals on behalf of their patients. While occupational therapists have not traditionally provided services in the primary care setting, occupational therapy services delivered in hospital, home, and community settings improve function and reduce healthcare costs among older adults. Occupational therapy services delivered in the primary care setting offers a unique opportunity to improve the health, function and wellbeing of frail, pre-frail, and at risk older adults (OA).
The purpose of the proposed research is to evaluate the feasibility and preliminary effectiveness of an occupational therapy intervention delivered through the primary care setting for improving frailty status and physical functioning among older adults (OA) ages 55 and older who are pre-frail when compared to usual care. Secondary aims include conducting exploratory analyses to examine potential mechanisms that may explain the intervention's effects, and evaluating the intervention's impact on secondary outcomes including occupational performance, quality of life, and care utilization.
The investigators hypothesize that occupational therapy services will result in greater improvement in the primary outcomes of frailty status (measured via the Fried Frailty criteria), physical function, and the secondary outcomes of occupational performance, health status (measured via weight and blood pressure), and care utilization (assessed via structured questionnaire) Quality of Life among the treatment group compared to usual care. The two specific aims of the study are:
- To evaluate intervention feasibility and acceptability. Determine if the occupational therapy services delivered are feasible and acceptable. By tracking time, effort, costs, adherence to recommendations, participant recruitment and retention rates, and intervention satisfaction among a sample of 150 pre-frail older adults, we expect to be able to provide data that both support the feasibility of the intervention and help us improve it for a subsequent study.
- To conduct a pilot randomized trial of the intervention components with 150 older adults to evaluate the impact of the occupational therapy intervention on the primary outcomes of frailty status and physical functioning, and the secondary outcomes of occupational performance, health status, quality of life and care usage. Hypotheses: Frailty status and physical functioning will be significantly improved following the intervention and will be maintained for 6-months after treatment termination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frailty Prevention Program | Experimental | Behavioral: Frailty Prevention Program4 face-to-face sessions, with a licensed and registered occupational therapist over 4 months |
| Educational materials | No intervention | –Participants receive publicly available educational materials |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Prefrail (meeting 1-2 of the following 5 criteria: self-report of loss of at least 10% of body weight over a 2-year period and the four following questions: (1) "Because of health problems, do you have any difficulty with lifting or carrying weights over 10 pounds, like a heavy bag of groceries?", (2) "Because of a health problem, do you have any difficulty with getting up from a chair after sitting for long periods?", (3) "Have you had any of the following persistent or troublesome problems: severe fatigue or exhaustion?", and (4) "Have you fallen down in the past 2 years?" )
- African American
- Age 55 and older
Key exclusion criteria (3 listed)
- Moderate to severe dementia
- A serious physical disability that requires a caregiver to provide care for basic activities of daily living
- A terminal illness (e.g., end stage renal disease or end stage cancer).
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 |
|---|---|---|
| Frailty Prevention Program4 face-to-face sessions, with a occupational therapist over 4 months to address function, safety, social participation, diet, exercise, sleep, and medication management. Sessions are expected to last between 60-120 minutes. The first session is a comprehensive occupational therapy evaluation and treatment plan. Sessions 2 and 3 involved physical activity and dietary education, counseling and goal setting. Session 4 involves reviewing program progress, and setting maintenance goals. | Behavioural | Frailty Prevention Program |
Primary outcome
Habit formation
Time frame: from week 0 to week 4
Self-reported Behavioral Automaticity index
Frailty
Time frame: From week 0 to week 16
Fried Frailty Index
4 secondary outcomes
Self Rate Quality of Life
Time frame: From week 0 to week 16
Social Participation
Time frame: From week 0 to week 16
Global Health
Time frame: From week 0 to week 16
Health Service Utilization
Time frame: From week 0 to week 40
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 30 Aug 2019.
- 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.
Heather Fritz, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frailty Prevention Program in people with Frail Elderly Syndrome, run by Wayne State University at 1 site 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 3 inclusion and 3 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 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Habit formation (time frame: from week 0 to week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2019.