Frailty Prevention Program to Prevent Frailty Among Older African Americans

NCT03585972 | Completed

• 1 other identifier: 1701000204
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Frail Elderly Syndrome

Outcome Measures

Primary Outcomes (2)

• Habit formation

  Self-reported Behavioral Automaticity index

  from week 0 to week 4

• Frailty

  Fried Frailty Index

  From week 0 to week 16

Secondary Outcomes (4)

• Self Rate Quality of Life

  From week 0 to week 16

• Social Participation

  From week 0 to week 16

• Global Health

  From week 0 to week 16

• Health Service Utilization

  From week 0 to week 40

Study Arms (2)

Frailty Prevention Program

EXPERIMENTAL

4 face-to-face sessions, with a licensed and registered occupational therapist over 4 months

Behavioral: Frailty Prevention Program

Educational materials

NO INTERVENTION

Participants receive publicly available educational materials

Interventions

Frailty Prevention Program BEHAVIORAL

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.

Frailty Prevention Program

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Wayne State University: lead
• Michigan Health Endowment Fund: collaborator

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

Location

Study Officials

• Heather Fritz, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors do not know which arm participants were assigned to.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Occupational Therapy and Gerontology

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 13, 2018
• Study Start: May 5, 2018
• Primary Completion: May 28, 2019
• Study Completion: May 28, 2019
• Last Updated: August 30, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)