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CompletedNCT00985283Updated Sep 16, 2011

Feasibility and Effects of Preventive Home Visits for Older Adults

An interventional study of Preventive home visit and minimal intervention in Frailty, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 75 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-09-16.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
75 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Frailty

Keywords

  • prevention
  • older adults
  • function
  • participation
  • life satisfaction
  • self-rated health
03

In context

Frailty

1,229 studies on the registry are indexed under Frailty; 433 are open to participants now.

This study's enrollment of 110 is above the median of 80 across 704 interventional studies indexed under Frailty.

Browse Frailty studies →

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,366 studies on the registry; 133 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 139 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    Preventive home visit

    receives preventive home visit intervention 4 times over 1 year

    Behavioral: Preventive home visit

  • Active comparator
    comparison group

    receives information packets on local services for older adults and health promotion material twice during 1 year

    Behavioral: minimal intervention

Interventions

  • BehavioralPreventive 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

  • Behavioralminimal intervention

    provision of information related to services and health promotion for older adults as a low-cost minimal alternative to the intervention

06

What researchers measure

Primary outcomes

  1. functional ability

    Time frame: 5 times across approx. 15 months

Secondary outcomes

  1. life satisfaction

    Time frame: 5 times across approx. 15 months

07

Study locations

1 site
  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27516, United States
08

References and documents

Publications

  • 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. PubMed 19958547 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00985283
Responsible party
Sponsor
First posted
Sep 28, 2009
Start date
Jan 2008
Primary completion
May 2010
Completion
May 2010
Last update
Sep 16, 2011

Study contacts

Malcolm P. Cutchin, PhD
principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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