Chronic Heart FailureNCT01794598
Preliminary Study Examining Heart Failure Patients Responses to Depression Education
A study testing Receiving educational material of depression care in people with Chronic Heart Failure, run by Duke University.
Trial summary
Purpose of the Study: The significant impact of depression on the poor prognosis and functional restrain, recognition and successful treatment of depression in patients with Chronic Heart Failure (CHF) may result in improvement of overall outcome of those patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Receiving educational material of depression care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Dec 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LVEF ≤ 35%.
- NYHA class II, III, or IV heart failure for the previous three months despite a minimum of 6 weeks of treatment.
- Must be on optimal heart failure therapy according to AHA/ACC and HFSA heart failure guidelines, including treatment with ACEI and beta-blocker therapy, or have documented rationale for variation, including intolerance, contraindication, patient preference, or personal physician's judgment.
Who cannot join
- Age less than 18.
- Currently pregnant or intending to become pregnant in the next year.
- Cardiovascular procedure or hospitalization for any reason planned in the next 6 months.
- Expectation of receiving a cardiac transplant in the next six months.
- Unable to provide the study consent.
- Participation another clinical trial(s) that may interfere with follow-up or data collection for this study, or that may affect cardiovascular mortality.
About this study
Official title: HF-ACTION Depression Education Substudy
Purpose of the Study: The significant impact of depression on the poor prognosis and functional restrain, recognition and successful treatment of depression in patients with Chronic Heart Failure (CHF) may result in improvement of overall outcome of those patients. However, depression comorbid with CHF has been overlooked in the real practice. Therefore, the investigators are proposing a study to 1) assess the prognostic impact of depression in patients with stable CHF who have been managed as outpatients, and 2) assess whether provision of depression education to CHF patients will improve the care of depression.
Patients with chronic heart failure are enrolled into this study with a half of them are randomly assigned to receive a packet of depression education materials and then other half not. Participants and investigators both are blinded to the assignment. All the participants are provided a toll free phone number to contact the research team as needed. Depressive symptoms and patients knowledge of depression are assessed at baseline prior to randomization and at 1-month and 6-month following the enrollment.
Responses of the study participants, such as change of depressive symptoms, and requests for psychiatric help are examined between two groups.
- Conditions
- Chronic Heart Failure
- Being tested
- Receiving educational material of depression care
- Keywords
- Heart failure, depression, depression care education
- Medical subject headings
- Heart Failure, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receiving educational material of depression careBehavioural
The educational material provides patients about depression management
| Study group | Role | What they receive |
|---|---|---|
| Educational materials | Experimental | Receiving educational materials of depression care Receives: Behavioral: Receiving educational material of depression care |
| No educational materials | Sham comparator | Receiving an envelope but no inclusion of educational materials of depression care Receives: Behavioral: Receiving educational material of depression care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in recognition of study participant to depression care
To assess whether the provision of depression education materials will increase knowledge of the impact depression has on Congestive Heart Failure patients. This will be measured through study participants completion of a questionnaire to record their views on depression and depression care in a non-psychiatric setting.
Measured: Baseline, 1 month and 6 months
Secondary outcomes (1)
Change in response of study participant to depression care
Response of participants to depression care was measured by use of the Beck Depression Inventory scale (BDI), PHQ-9 (the 9 items of the depression scale of the Patient Health Questionnaire) and an anxiety questionnaire and a toll-free contact number to access free psychiatric consultants at the coordinating center. A contact log was kept documenting subject ID, reason for call, number of contacts and duration of the call.
Measured: Baseline, 1 month, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startMay 2004
- Primary completionDec 2006
- Study completionDec 2006
Why it stopped: Terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Jiang, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794598
- Sponsor's protocol ID
- 5132
- Other IDs
- 5132-03-8R0ER
- Status last verified
- Feb 2013
- First submitted
- 17 Feb 2012
- Last updated
- 22 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HF-ACTION Depression Education Substudy
- ClinicalTrials.gov ID
- NCT01794598
- Acronym / sponsor ID
- 5132
- Conditions
- Chronic Heart Failure
- Keywords
- Heart failure, depression, depression care education
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 20 Feb 2013 (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.
Purpose of the Study: The significant impact of depression on the poor prognosis and functional restrain, recognition and successful treatment of depression in patients with Chronic Heart Failure (CHF) may result in improvement of overall outcome of those patients. However, depression comorbid with CHF has been overlooked in the real practice. Therefore, the investigators are proposing a study to 1) assess the prognostic impact of depression in patients with stable CHF who have been managed as outpatients, and 2) assess whether provision of depression education to CHF patients will improve the care of depression.
Patients with chronic heart failure are enrolled into this study with a half of them are randomly assigned to receive a packet of depression education materials and then other half not. Participants and investigators both are blinded to the assignment. All the participants are provided a toll free phone number to contact the research team as needed. Depressive symptoms and patients knowledge of depression are assessed at baseline prior to randomization and at 1-month and 6-month following the enrollment.
Responses of the study participants, such as change of depressive symptoms, and requests for psychiatric help are examined between two groups.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational materials | Experimental | Behavioral: Receiving educational material of depression careReceiving educational materials of depression care |
| No educational materials | Sham comparator | Behavioral: Receiving educational material of depression careReceiving an envelope but no inclusion of educational materials of depression care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- LVEF ≤ 35%.
- NYHA class II, III, or IV heart failure for the previous three months despite a minimum of 6 weeks of treatment.
- Must be on optimal heart failure therapy according to AHA/ACC and HFSA heart failure guidelines, including treatment with ACEI and beta-blocker therapy, or have documented rationale for variation, including intolerance, contraindication, patient preference, or personal physician's judgment.
Key exclusion criteria (6 listed)
- Age less than 18.
- Currently pregnant or intending to become pregnant in the next year.
- Cardiovascular procedure or hospitalization for any reason planned in the next 6 months.
- Expectation of receiving a cardiac transplant in the next six months.
- Unable to provide the study 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 |
|---|---|---|
| Receiving educational material of depression careThe educational material provides patients about depression management | Behavioural | Educational materials, No educational materials |
Primary outcome
Change in recognition of study participant to depression care
Time frame: Baseline, 1 month and 6 months
To assess whether the provision of depression education materials will increase knowledge of the impact depression has on Congestive Heart Failure patients. This will be measured through study participants completion of a questionnaire to record their views on depression and depression care in a non-psychiatric setting.
1 secondary outcome
Change in response of study participant to depression care
Time frame: Baseline, 1 month, and 6 months
Results and safety
The study was stopped early (reason given: Terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2014.
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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.
Wei Jiang, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A study testing Receiving educational material of depression care in people with Chronic Heart Failure, run by Duke University.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 22 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Terminated). Results are not available in the source record.
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?
Change in recognition of study participant to depression care (time frame: Baseline, 1 month and 6 months). 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 22 Sep 2014.