Working AdultsNCT00953030
Cost Effective Health Promotion for Older Adults
A study testing COACH and RealAge in people with Working Adults, run by University of Illinois Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Working Adults
- What is being tested?
- COACH and RealAge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 423 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jul 2008
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current employee of the University of Illinois at Chicago
- 40+ years of age
Who cannot join
- Those not currently employed by the University of Illinois at Chicago
- Those under the age of 40
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Chicago
Chicago, Illinois, 60608
About this study
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.
Read more
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.
- Conditions
- Working Adults
- Being tested
- COACH, RealAge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COACHBehavioural
RealAgeBehavioural
| Study group | Role | What they receive |
|---|---|---|
| COACH | Experimental | web-based risk assessments with an action plan that is negotiated with a "Coach" who provides personalized follow-up reinforcement Receives: Behavioral: COACH |
| RealAge | Experimental | a web-based health risk assessment and risk profile with disease-specific follow-up reinforcement modules Receives: Behavioral: RealAge |
| light health education control | No intervention | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startSep 2004
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Working AdultsStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953030
- Sponsor's protocol ID
- R01DP000094
- Status last verified
- Aug 2009
- First submitted
- 5 Aug 2009
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Effective Health Promotion for Older Adults
- ClinicalTrials.gov ID
- NCT00953030
- Acronym / sponsor ID
- R01DP000094
- Conditions
- Working Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COACH | Experimental | Behavioral: COACHweb-based risk assessments with an action plan that is negotiated with a "Coach" who provides personalized follow-up reinforcement |
| RealAge | Experimental | Behavioral: RealAgea web-based health risk assessment and risk profile with disease-specific follow-up reinforcement modules |
| light health education control | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current employee of the University of Illinois at Chicago
- 40+ years of age
Key exclusion criteria (2 listed)
- Those not currently employed by the University of Illinois at Chicago
- Those under the age of 40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COACH | Behavioural | COACH |
| RealAge | Behavioural | RealAge |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COACH and RealAge in people with Working Adults, run by University of Illinois Chicago 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 2 inclusion and 2 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 6 Aug 2009. 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.
Where can I read the original study information?
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 6 Aug 2009.