HealthyNCT00651495
Activating Seniors to Improve Chronic Disease Care
A study testing Patient decision aids for chronic conditions in people with Healthy, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
Chronic diseases are the primary cause of morbidity and mortality for older Americans. Active patient participation in treatment decision-making has the potential to significantly improve outcomes in chronic disease care, but interventions to increase participation remain underused. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Patient decision aids for chronic conditions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to Nov 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 55 years old.
- Able to ambulate
- Able to complete self-administered surveys
- Able to speak and read English
Who cannot join
- Not willing to provide consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Culver City Senior Center
Culver City, California, 90232
Willowbrook Senior Center
Los Angeles, California, 90061
About this study
Chronic diseases are the primary cause of morbidity and mortality for older Americans. Active patient participation in treatment decision-making has the potential to significantly improve outcomes in chronic disease care, but interventions to increase participation remain underused. Some studies have found that older individuals are less interested in participating in clinical decision-making, but other studies find that exposing patients to decision aids (PtDAs) increases their desire to take an active role in making decisions with their physicians. The present study targets hard-to-reach seniors by showing decision aids focused on chronic disease management in senior centers. Decision aids will be made available in two senior centers through a lending library and by conducting group screenings of the decision aids followed by moderated discussion of the content with participants. A randomized encouragement design will be used to test the effectiveness of a modest financial incentive on increasing seniors' participation in group screenings. The investigators will evaluate the effects of the intervention on seniors' decision-making role preferences, attitudes, perceived social norms and self efficacy for asking questions of their physician, health-related quality of life, physical activity, and changes in prescribed treatment regimens and self-care.
- Conditions
- Healthy
- Being tested
- Patient decision aids for chronic conditions
- Keywords
- Decision aids, Seniors, Chronic disease management, Advance directives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient decision aids for chronic conditionsBehavioural
Videos providing comprehensive information about chronic disease management
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants receive a $50 financial incentive if they view at least 3 of 5 patient decision aids in a group screening. Receives: Behavioral: Patient decision aids for chronic conditions |
| 2 | Active comparator | No financial incentive for watching patient decision aids in group screenings Receives: Behavioral: Patient decision aids for chronic conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision-making role preferences
Measured: 20 weeks
Attitudes, perceived social norms and self efficacy for asking questions of a physician
Measured: 20 weeks
Secondary outcomes (1)
Health-related quality of life
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Informed Medical Decision Making
- Responsible party
- Sponsor
- Investigators
- Dominick L Frosch, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651495
- Sponsor's protocol ID
- G07-09-025
- Other IDs
- FIMDM 0096-1
- Status last verified
- Nov 2016
- First submitted
- 28 Mar 2008
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Frosch DL, Rincon D, Ochoa S, Mangione CM. Activating seniors to improve chronic disease care: results from a pilot intervention study. J Am Geriatr Soc. 2010 Aug;58(8):1496-503. doi: 10.1111/j.1532-5415.2010.02980.x. Epub 2010 Jul 19.
PubMed 20662953
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activating Seniors to Improve Chronic Disease Care
- ClinicalTrials.gov ID
- NCT00651495
- Acronym / sponsor ID
- G07-09-025
- Conditions
- Healthy
- Keywords
- Decision aids, Seniors, Chronic disease management, Advance directives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Foundation for Informed Medical Decision Making
- Study start
- Apr 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 2 Apr 2008 (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.
Chronic diseases are the primary cause of morbidity and mortality for older Americans. Active patient participation in treatment decision-making has the potential to significantly improve outcomes in chronic disease care, but interventions to increase participation remain underused. Some studies have found that older individuals are less interested in participating in clinical decision-making, but other studies find that exposing patients to decision aids (PtDAs) increases their desire to take an active role in making decisions with their physicians. The present study targets hard-to-reach seniors by showing decision aids focused on chronic disease management in senior centers. Decision aids will be made available in two senior centers through a lending library and by conducting group screenings of the decision aids followed by moderated discussion of the content with participants. A randomized encouragement design will be used to test the effectiveness of a modest financial incentive on increasing seniors' participation in group screenings. The investigators will evaluate the effects of the intervention on seniors' decision-making role preferences, attitudes, perceived social norms and self efficacy for asking questions of their physician, health-related quality of life, physical activity, and changes in prescribed treatment regimens and self-care.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Patient decision aids for chronic conditionsParticipants receive a $50 financial incentive if they view at least 3 of 5 patient decision aids in a group screening. |
| 2 | Active comparator | Behavioral: Patient decision aids for chronic conditionsNo financial incentive for watching patient decision aids in group screenings |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 55 years old.
- Able to ambulate
- Able to complete self-administered surveys
- Able to speak and read English
Key exclusion criteria (1 listed)
- Not willing to provide consent
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 |
|---|---|---|
| Patient decision aids for chronic conditionsVideos providing comprehensive information about chronic disease management | Behavioural | 1, 2 |
Primary outcome
Decision-making role preferences
Time frame: 20 weeks
Attitudes, perceived social norms and self efficacy for asking questions of a physician
Time frame: 20 weeks
1 secondary outcome
Health-related quality of life
Time frame: 20 weeks
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 28 Nov 2016.
- Results publication: PubMed 20662953Frosch DL, Rincon D, Ochoa S, Mangione CM. Activating seniors to improve chronic disease care: results from a pilot intervention study. J Am Geriatr Soc. 2010 Aug;58(8):1496-503. doi: 10.1111/j.1532-5415.2010.02980.x. Epub 2010 Jul 19.
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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.
Dominick L Frosch, Ph.D. principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient decision aids for chronic conditions in people with Healthy, run by University of California, Los Angeles at 2 sites 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 1 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 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Decision-making role preferences (time frame: 20 weeks). The study lists 2 primary outcomes in all. 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 NCT00651495, 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 28 Nov 2016.