NCT00953030

Brief Summary

This project tests the cost-effectiveness of two promising evidence-based health promotion/ behavior change interventions. The first intervention is the COACH Program, a revised version of the Health Enhancement Program (HEP) that has been implemented to date with older adults at multiple Senior Centers across the country (Leveille et al, 1998). The second is the web-based RealAge program which is also being implemented for older adults at multiple sites nationally and internationally. The Coach program combines a web-based risk assessment with individualized counselling. In contrast, RealAge is a totally web-based program. The specific hypotheses that we will test in the proposed cost-effectiveness study are shown below. Primary Study Hypotheses: COACH participants will experience significantly greater reductions in absenteeism, disability days, and healthcare use and cost at 6 and 12 months than RealAge participants. Participants in both the COACH and RealAge treatment groups will experience significantly greater reductions in absenteeism, disability days, and healthcare use and cost than control group participants at 6 and 12 months. Secondary Study Hypotheses: COACH participants will experience significantly greater levels of adherence to health promotion Action Plans and greater reduction in weight, body mass index, blood pressure and depression and greater increase in vitality and quality of life than RealAge participants at 6 and 12 months. Participants in both the COACH and RealAge treatment arms will experience significantly better outcomes on these measures at 6 and 12 months than control group participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
423

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
Last Updated

August 6, 2009

Status Verified

August 1, 2009

Enrollment Period

3.8 years

First QC Date

August 5, 2009

Last Update Submit

August 5, 2009

Conditions

Study Arms (3)

COACH

EXPERIMENTAL

web-based risk assessments with an action plan that is negotiated with a "Coach" who provides personalized follow-up reinforcement

Behavioral: COACH

RealAge

EXPERIMENTAL

a web-based health risk assessment and risk profile with disease-specific follow-up reinforcement modules

Behavioral: RealAge

light health education control

NO INTERVENTION

Interventions

COACHBEHAVIORAL
COACH
RealAgeBEHAVIORAL
RealAge

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current employee of the University of Illinois at Chicago
  • + years of age

You may not qualify if:

  • Those not currently employed by the University of Illinois at Chicago
  • Those under the age of 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60608, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 6, 2009

Study Start

September 1, 2004

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

August 6, 2009

Record last verified: 2009-08

Locations