Heart FailureACT-HFNCT01064765
ACT-HF: Attention, Cognition and Self-Management in Heart Failure
An observational study of Heart Failure, run by University of Chicago at 1 site in United States.
Trial summary
This study is designed to determine if a relationship exists between problems with memory, attention, learning, insight and executive function and self management in heart failure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Mar 2011
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with history of heart failure 6 months or more meeting inclusion criteria recruited from outpatient clinic who receiving routine care for their heart failure
Who may be able to join
- 75 years of age or less
- ejection fraction 40% or less
- heart failure 6 months or more
- English speaking
- no known dementia
- no active substance abuse
- presence of caregiver/support
Who cannot join
- neurologic disorders potentially causing cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
This study is designed to determine if a relationship exists between problems with memory, attention, learning, insight and executive function and self management in heart failure.
Read the detailed description
Eligible participants are those 75 years of age or less, with left ventricular ejection fractions of 40% or less, english speaking and no known cognitive deficits. Participants will be administered the Repeatable Battery for the Assessment of Neuropsychological Status and the Controlled Oral Word Association test at the study visit. They will also be asked to complete the Self-Care in Heart Failure Index and the Anosognosia Questionnaire for Dementia at their convenience and mail back to investigator. Participants will be contacted in 90 days to determine if they have been hospitalized, and if so, for how many days.
- Conditions
- Heart Failure
- Keywords
- Heart failure, Self management, cognitive dysfunction, Self management of heart failure
- Medical subject headings
- Heart Failure, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure | Outpatients with heart failure, age 75 or less, left ventricular ejection fraction 40% or less, english speaking with no known dementia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-management of heart failure as measured by the Self-Care in Heart Failure Index
Measured: at time of enrollment
Secondary outcomes (1)
Duration of hospitalization(s)
Measured: 90 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startSep 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Sigma-Tau Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Savitri E. Fedson, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064765
- Sponsor's protocol ID
- 16233A
- Acronym
- ACT-HF
- Status last verified
- Sep 2013
- First submitted
- 3 Feb 2010
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACT-HF: Attention, Cognition and Self-Management in Heart Failure
- ClinicalTrials.gov ID
- NCT01064765
- Acronym / sponsor ID
- ACT-HF / 16233A
- Conditions
- Heart Failure
- Keywords
- Heart failure, Self management, cognitive dysfunction, Self management of heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Sigma-Tau Research, Inc.
- Study start
- Sep 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 8 Feb 2010 (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 study is designed to determine if a relationship exists between problems with memory, attention, learning, insight and executive function and self management in heart failure.
Detailed description
Eligible participants are those 75 years of age or less, with left ventricular ejection fractions of 40% or less, english speaking and no known cognitive deficits. Participants will be administered the Repeatable Battery for the Assessment of Neuropsychological Status and the Controlled Oral Word Association test at the study visit. They will also be asked to complete the Self-Care in Heart Failure Index and the Anosognosia Questionnaire for Dementia at their convenience and mail back to investigator. Participants will be contacted in 90 days to determine if they have been hospitalized, and if so, for how many days.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure | – | –Outpatients with heart failure, age 75 or less, left ventricular ejection fraction 40% or less, english speaking with no known dementia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with history of heart failure 6 months or more meeting inclusion criteria recruited from outpatient clinic who receiving routine care for their heart failure
Key inclusion criteria (7 listed)
- 75 years of age or less
- ejection fraction 40% or less
- heart failure 6 months or more
- English speaking
- no known dementia
Key exclusion criteria (1 listed)
- neurologic disorders potentially causing cognitive dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-management of heart failure as measured by the Self-Care in Heart Failure Index
Time frame: at time of enrollment
1 secondary outcome
Duration of hospitalization(s)
Time frame: 90 days after enrollment
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 5 Sep 2013.
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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.
Savitri E. Fedson, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by University of 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 7 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 5 Sep 2013. 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?
Self-management of heart failure as measured by the Self-Care in Heart Failure Index (time frame: at time of enrollment). It is what the study was designed to measure, not a finding.
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 5 Sep 2013.