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FrailtyNCT00985283

Feasibility and Effects of Preventive Home Visits for Older Adults

A study testing Preventive home visit and minimal intervention in people with Frailty, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 75 years and olderHealthy volunteers can take part
Conditions the study is for
Frailty
What is being tested?
Preventive home visit and minimal intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteUnited States
Study dates
Jan 2008to May 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27516

Other trials in United States

About this study

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.

Conditions
Frailty
Being tested
Preventive home visit, minimal intervention
Keywords
prevention, older adults, function, participation, life satisfaction, self-rated health
Medical subject headings
Frailty, Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preventive home visitBehavioural

    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 interventionBehavioural

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

Study groups in NCT00985283
Study groupRoleWhat they receive
Preventive home visitExperimentalreceives preventive home visit intervention 4 times over 1 year
Receives: Behavioral: Preventive home visit
comparison groupActive comparatorreceives information packets on local services for older adults and health promotion material twice during 1 year
Receives: Behavioral: minimal intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. functional ability

    Measured: 5 times across approx. 15 months

Secondary outcomes (1)
  1. life satisfaction

    Measured: 5 times across approx. 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2009 (estimated)
  2. Study startJan 2008
  3. Primary completionMay 2010
  4. Study completionMay 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00985283
Sponsor's protocol ID
R21-AG29502-2
Other IDs
R21-AG29502-2, R21AG029502
Status last verified
Sep 2011
First submitted
25 Sep 2009
Last updated
16 Sep 2011
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Preventive home visit and minimal intervention in people with Frailty, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

functional ability (time frame: 5 times across approx. 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00985283, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2011.

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