Feasibility and Effects of Preventive Home Visits for Older Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00985283
First received: September 25, 2009
Last updated: September 15, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Frailty
Behavioral: Preventive home visit
Behavioral: minimal intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Feasibility and Effects of Preventive Home Visits for Older Adults

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • functional ability [ Time Frame: 5 times across approx. 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • life satisfaction [ Time Frame: 5 times across approx. 15 months ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: January 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preventive home visit
receives preventive home visit intervention 4 times over 1 year
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
Active Comparator: comparison group
receives information packets on local services for older adults and health promotion material twice during 1 year
Behavioral: minimal intervention
provision of information related to services and health promotion for older adults as a low-cost minimal alternative to the intervention

Detailed 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.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985283

Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27516
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Malcolm P. Cutchin, PhD University of North Carolina, Chapel Hill
  More Information

No publications provided by University of North Carolina, Chapel Hill

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00985283     History of Changes
Other Study ID Numbers: R21-AG29502-2, R21-AG29502-2
Study First Received: September 25, 2009
Last Updated: September 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
prevention
older adults
function
participation
life satisfaction
self-rated health

ClinicalTrials.gov processed this record on October 20, 2014