Cognitive ImpairmentHeart ABCNCT01461629
Self-management and Cognitive Function in Adults With Heart Failure
An observational study of Cognitive Impairment and Cardiac Disease, run by Kent State University at 1 site in United States.
Trial summary
The purpose of this study is to assess the relationship between cognitive impairment, patient self-management, health, and health service use in adults with heart failure (NYHA Class 2 and 3). The research questions are: 1. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Cognitive Impairment, Cardiac Disease, Heart Failure
- How many people
- 372 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Apr 2015
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 50-85 years of age, documented diagnosis of systolic heart failure (EF </= 35%) at least 12 months prior to enrollment
Who may be able to join
- documented systolic heart failure
- NYHA class II, III of at least 6 months duration
- 50-85 years of age
- has a telephone (land line) or be willing to allow a telephone installed for duration of study
Who cannot join
- history of neurological disorder or injury
- moderate or severe head injury
- past or current history of severe psychiatric illness; specifically, psychotic disorders and bipolar disorder
- 5 year past or current history of alcohol or drug abuse
- history of learning disorder or developmental disability
- renal failure requiring dialysis
Show all 9Show fewer
- history of sleep apnea
- current home telemonitoring program to assist w/ HF self-management
- cardiac surgery < 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Impairment and Self-management in Adults With Heart Failure
The purpose of this study is to assess the relationship between cognitive impairment, patient self-management, health, and health service use in adults with heart failure (NYHA Class 2 and 3). The research questions are:
- How is cognitive impairment (memory, attention, global and executive function) related to various aspects of impaired self-management (knowledge of adherence, adherence to sodium restriction and medications, symptom monitoring of weight changes, and decision and action to seek care)?
- How are these relationships altered when adjusting for medical, demographic, and psychosocial factors?
- What are the relationships among degree of cognitive impairment, quality self-management, health status, and health service use?
- Conditions
- Cognitive Impairment, Cardiac Disease, Heart Failure
- Keywords
- cognitive impairment, cognitive function, hospitalization, self-management, cardiac disease, heart failure
- Medical subject headings
- Cognitive Dysfunction, Heart Diseases, Heart Failure
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 | left systolic heart failure (EF </= 40%) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startJun 2010
- Primary completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kent State University
- Sponsor type
- University, hospital or other
- Collaborators
- Summa Health System, Case Western Reserve University, University Hospitals Cleveland Medical Center
- Responsible party
- Principal investigator, Tony Vehovec, Kent State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461629
- Sponsor's protocol ID
- 10217650
- Other IDs
- 10217650
- Acronym
- Heart ABC
- Status last verified
- Apr 2016
- First submitted
- 26 Oct 2011
- Last updated
- 7 Apr 2016
- Results posted
- No
Publications
Kuhn TA, Gathright EC, Dolansky MA, Gunstad J, Josephson R, Hughes JW. Health Literacy, Cognitive Function, and Mortality in Patients With Heart Failure. J Cardiovasc Nurs. 2022 Jan-Feb 01;37(1):50-55. doi: 10.1097/JCN.0000000000000855.
PubMed 34581712Walter FA, Ede D, Hawkins MAW, Dolansky MA, Gunstad J, Josephson R, Moore SM, Hughes JW. Sleep quality and daytime sleepiness are not associated with cognition in heart failure. J Psychosom Res. 2018 Oct;113:100-106. doi: 10.1016/j.jpsychores.2018.08.003. Epub 2018 Aug 10.
PubMed 30190041Dolansky MA, Hawkins MA, Schaefer JT, Sattar A, Gunstad J, Redle JD, Josephson R, Moore SM, Hughes JW. Association Between Poorer Cognitive Function and Reduced Objectively Monitored Medication Adherence in Patients With Heart Failure. Circ Heart Fail. 2016 Dec;9(12):e002475. doi: 10.1161/CIRCHEARTFAILURE.116.002475.
PubMed 27895069Basuray A, Dolansky M, Josephson R, Sattar A, Grady EM, Vehovec A, Gunstad J, Redle J, Fang J, Hughes JW. Dietary sodium adherence is poor in chronic heart failure patients. J Card Fail. 2015 Apr;21(4):323-9. doi: 10.1016/j.cardfail.2014.12.016. Epub 2015 Jan 7.
PubMed 25576680
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairment and Self-management in Adults With Heart Failure
- ClinicalTrials.gov ID
- NCT01461629
- Acronym / sponsor ID
- Heart ABC / 10217650
- Conditions
- Cognitive Impairment, Cardiac Disease, Heart Failure
- Keywords
- cognitive impairment, cognitive function, hospitalization, self-management, cardiac disease, heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Kent State UniversityUniversity, hospital or other
- Collaborators
- Summa Health System, Case Western Reserve University, University Hospitals Cleveland Medical Center
- Study start
- Jun 2010
- Primary completion
- Apr 2015 (actual)
- First posted
- 28 Oct 2011 (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.
The purpose of this study is to assess the relationship between cognitive impairment, patient self-management, health, and health service use in adults with heart failure (NYHA Class 2 and 3). The research questions are:
- How is cognitive impairment (memory, attention, global and executive function) related to various aspects of impaired self-management (knowledge of adherence, adherence to sodium restriction and medications, symptom monitoring of weight changes, and decision and action to seek care)?
- How are these relationships altered when adjusting for medical, demographic, and psychosocial factors?
- What are the relationships among degree of cognitive impairment, quality self-management, health status, and health service use?
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| heart failure | – | –left systolic heart failure (EF </= 40%) |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50-85 years of age, documented diagnosis of systolic heart failure (EF </= 35%) at least 12 months prior to enrollment
Key inclusion criteria (4 listed)
- documented systolic heart failure
- NYHA class II, III of at least 6 months duration
- 50-85 years of age
- has a telephone (land line) or be willing to allow a telephone installed for duration of study
Key exclusion criteria (9 listed)
- history of neurological disorder or injury
- moderate or severe head injury
- past or current history of severe psychiatric illness; specifically, psychotic disorders and bipolar disorder
- 5 year past or current history of alcohol or drug abuse
- history of learning disorder or developmental disability
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
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 7 Apr 2016.
- Derived from this study: PubMed 34581712Kuhn TA, Gathright EC, Dolansky MA, Gunstad J, Josephson R, Hughes JW. Health Literacy, Cognitive Function, and Mortality in Patients With Heart Failure. J Cardiovasc Nurs. 2022 Jan-Feb 01;37(1):50-55. doi: 10.1097/JCN.0000000000000855.
- Derived from this study: PubMed 30190041Walter FA, Ede D, Hawkins MAW, Dolansky MA, Gunstad J, Josephson R, Moore SM, Hughes JW. Sleep quality and daytime sleepiness are not associated with cognition in heart failure. J Psychosom Res. 2018 Oct;113:100-106. doi: 10.1016/j.jpsychores.2018.08.003. Epub 2018 Aug 10.
- Derived from this study: PubMed 27895069Dolansky MA, Hawkins MA, Schaefer JT, Sattar A, Gunstad J, Redle JD, Josephson R, Moore SM, Hughes JW. Association Between Poorer Cognitive Function and Reduced Objectively Monitored Medication Adherence in Patients With Heart Failure. Circ Heart Fail. 2016 Dec;9(12):e002475. doi: 10.1161/CIRCHEARTFAILURE.116.002475.
- Derived from this study: PubMed 25576680Basuray A, Dolansky M, Josephson R, Sattar A, Grady EM, Vehovec A, Gunstad J, Redle J, Fang J, Hughes JW. Dietary sodium adherence is poor in chronic heart failure patients. J Card Fail. 2015 Apr;21(4):323-9. doi: 10.1016/j.cardfail.2014.12.016. Epub 2015 Jan 7.
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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?
An observational study of Cognitive Impairment and Cardiac Disease, run by Kent State University 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 4 inclusion and 9 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 7 Apr 2016. 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?
On the ClinicalTrials.gov record for NCT01461629, which also lists 4 linked publications.
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 7 Apr 2016.