Feasibility and Effects of Preventive Home Visits for Older Adults
Primary Purpose
Frailty
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preventive home visit
minimal intervention
Sponsored by
About this trial
This is an interventional prevention trial for Frailty focused on measuring prevention, older adults, function, participation, life satisfaction, self-rated health
Eligibility 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
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Preventive home visit
comparison group
Arm Description
receives preventive home visit intervention 4 times over 1 year
receives information packets on local services for older adults and health promotion material twice during 1 year
Outcomes
Primary Outcome Measures
functional ability
Secondary Outcome Measures
life satisfaction
Full Information
NCT ID
NCT00985283
First Posted
September 25, 2009
Last Updated
September 15, 2011
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT00985283
Brief Title
Feasibility and Effects of Preventive Home Visits for Older Adults
Official Title
Feasibility and Effects of Preventive Home Visits for Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
prevention, older adults, function, participation, life satisfaction, self-rated health
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preventive home visit
Arm Type
Experimental
Arm Description
receives preventive home visit intervention 4 times over 1 year
Arm Title
comparison group
Arm Type
Active Comparator
Arm Description
receives information packets on local services for older adults and health promotion material twice during 1 year
Intervention Type
Behavioral
Intervention Name(s)
Preventive home visit
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
minimal intervention
Intervention Description
provision of information related to services and health promotion for older adults as a low-cost minimal alternative to the intervention
Primary Outcome Measure Information:
Title
functional ability
Time Frame
5 times across approx. 15 months
Secondary Outcome Measure Information:
Title
life satisfaction
Time Frame
5 times across approx. 15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malcolm P. Cutchin, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19958547
Citation
Cutchin MP, Coppola S, Talley V, Svihula J, Catellier D, Shank KH. Feasibility and effects of preventive home visits for at-risk older people: design of a randomized controlled trial. BMC Geriatr. 2009 Dec 3;9:54. doi: 10.1186/1471-2318-9-54.
Results Reference
derived
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Feasibility and Effects of Preventive Home Visits for Older Adults
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