NCT00985283

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

September 16, 2011

Status Verified

September 1, 2011

Enrollment Period

2.3 years

First QC Date

September 25, 2009

Last Update Submit

September 15, 2011

Conditions

Keywords

preventionolder adultsfunctionparticipationlife satisfactionself-rated health

Outcome Measures

Primary Outcomes (1)

  • functional ability

    5 times across approx. 15 months

Secondary Outcomes (1)

  • life satisfaction

    5 times across approx. 15 months

Study Arms (2)

Preventive home visit

EXPERIMENTAL

receives preventive home visit intervention 4 times over 1 year

Behavioral: Preventive home visit

comparison group

ACTIVE COMPARATOR

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

Behavioral: minimal intervention

Interventions

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

Preventive home visit

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

comparison group

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27516, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

FrailtyPersonal Satisfaction

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Malcolm P. Cutchin, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2009

First Posted

September 28, 2009

Study Start

January 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

September 16, 2011

Record last verified: 2011-09

Locations