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Frailty Prevention Program to Prevent Frailty Among Older African Americans (FPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03585972
Recruitment Status : Completed
First Posted : July 13, 2018
Last Update Posted : August 30, 2019
Michigan Health Endowment Fund
Information provided by (Responsible Party):
Heather Fritz, Wayne State University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Frail Elderly Syndrome Behavioral: Frailty Prevention Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessors do not know which arm participants were assigned to.
Primary Purpose: Prevention
Official Title: Occupational Therapy Services to Improve Frailty Status
Actual Study Start Date : May 5, 2018
Actual Primary Completion Date : May 28, 2019
Actual Study Completion Date : May 28, 2019

Arm Intervention/treatment
Experimental: Frailty Prevention Program
4 face-to-face sessions, with a licensed and registered occupational therapist over 4 months
Behavioral: Frailty Prevention Program
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.

No Intervention: Educational materials
Participants receive publicly available educational materials

Primary Outcome Measures :
  1. Habit formation [ Time Frame: from week 0 to week 4 ]
    Self-reported Behavioral Automaticity index

  2. Frailty [ Time Frame: From week 0 to week 16 ]
    Fried Frailty Index

Secondary Outcome Measures :
  1. Self Rate Quality of Life [ Time Frame: From week 0 to week 16 ]
    WHOQOL BREF (brief version)

  2. Social Participation [ Time Frame: From week 0 to week 16 ]
    NIH PROMISE Ability to Participate & Satisfaction with Social Roles (Short forms 8a)

  3. Global Health [ Time Frame: From week 0 to week 16 ]
    NIH PROMISE Global Health form

  4. Health Service Utilization [ Time Frame: From week 0 to week 40 ]
    Narrative self-report of services

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

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 identifier (NCT number): NCT03585972

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United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
Michigan Health Endowment Fund
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Principal Investigator: Heather Fritz, PhD Wayne State University
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Responsible Party: Heather Fritz, Assistant Professor of Occupational Therapy and Gerontology, Wayne State University Identifier: NCT03585972    
Other Study ID Numbers: 1701000204
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 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
Additional relevant MeSH terms:
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Pathologic Processes