Feasibility and Effects of Preventive Home Visits for Older Adults

Frailty Clinical Trial

Official title:

Feasibility and Effects of Preventive Home Visits for Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00985283
• Other study ID #: R21-AG29502-2
• Secondary ID: R21-AG29502-2
• Status: Completed
• Phase: N/A
• First received: September 25, 2009
• Last updated: September 15, 2011
• Start date: January 2008
• Est. completion date: May 2010

Study information

• Verified date: September 2011
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The goals of this project are to implement an innovative intervention for older adults and assess both its feasibility and effects on health and well-being. The investigators hypothesize that the intervention group will show a significantly better slope for a range of outcomes during and after the intervention.

Description:

Aging in place is now recognized as a goal of most older adults. While medically driven interventions such as home health care assist older adults to age in place, these occur not as true preventive measures but as reactions to losses in function or health. The search for preventive methods to mitigate decline and unwanted moves from home and community is important. One such method, Preventive Home Visits (PHVs), has been utilized in parts of Europe for approximately two decades. The PHV model is based on infrequent but regular visits to an older adult's home by a trained practitioner (typically an occupational therapist or nurse). The visit is designed to assess the older person's situation and provide information and advice to optimize function and well-being. Evidence about PHV efficacy is mixed but generally supportive, and there is a distinct need to create and examine a preventive non-medical intervention model in the USA. A successfully developed and implemented approach could enhance lives and save costs. We plan to implement an intervention informed by a framework based on a synthesis of the World Health Organization function and disability model and the Occupational Therapy Practice Framework. We aim to implement and evaluate this PHV intervention in Orange County, North Carolina to assess the feasibility and effects of preventive home visits with older adults. We will use an experimental, repeated measures design in which approximately 120 older (75+ years) community-dwelling adults who are at-risk for functional decline are randomly assigned to experimental and comparison groups. The experimental group will receive the PHV intervention four times across a 12 month period. The comparison group will receive a minimal intervention of two informational phone calls and printed materials about local services during the same period. An occupational therapist with the requisite training and experience in home-based evaluation and intervention will conduct the experimental intervention. We will independently administer a set of standardized scales to both groups immediately pre-intervention, and again at regular intervals after each intervention. These outcome measures will cover the primary dimensions on which we hypothesize PHVs will have a positive influence: functional ability, participation, self-efficacy, life satisfaction, and self-reported health. Secondary outcomes include hospitalization and institutionalization. Analyses will compare the differences in outcomes for the two groups as well as assess several dimensions of intervention feasibility. These data will be the basis for a subsequent, enhanced intervention and study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• 75 years or older

• lives in community (not in nursing home or assisted living)

• not currently receiving home health services

• vulnerable elders survey score of 3 or higher

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Frailty

Intervention

Behavioral:
• Preventive home visit
in-home visit by a trained occupational therapist to assess older adult's living context and occupational performance and to provide recommendations for changes or continuation of behavior or context
• minimal intervention
provision of information related to services and health promotion for older adults as a low-cost minimal alternative to the intervention

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional ability		5 times across approx. 15 months	No
Secondary	life satisfaction		5 times across approx. 15 months	No