Heart Failure, SystolicPhase 2/3NCT02044211
Blended Collaborative Care for Heart Failure and Co-Morbid Depression
A Phase 2/3 study testing Collaborative Care for Heart Failure and Collaborative Care for Depression in people with Heart Failure, Systolic and Depression, run by University of Pittsburgh at 1 site in United States.
Trial summary
Depression is highly prevalent among patients with heart failure (HF) and associated with lower levels of health-related quality of life and physical functioning, and higher risk of rehospitalization and mortality, and higher health costs. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure, Systolic, Depression, Cardiovascular Disease
- What is being tested?
- Collaborative Care for Heart Failure and Collaborative Care for Depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 756 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jul 2020
- Phase
- Phase 2/3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systolic heart failure (documented ejection fraction ≤ 40%).
- HF symptoms meeting criteria for New York Heart Association (NYHA) classes II, III or IV.
- Inpatient two-item Patient Health Questionnaire (PHQ-2) screen-positive for depression; or PHQ-2 screen negative for depression and PHQ-9 <5 if non-depressed control.
- PHQ-9 ≥ 10 when reassessed two-weeks following hospital discharge, or PHQ-9 <5 if non-depressed control.
- No cognitive impairment (as documented in the record, use of donepezil or similar medications for treating cognitive impairment, or the Montreal Cognitive Assessment).
- Able to be evaluated and treated for depression as an outpatient.
- English speaking, not illiterate, or possessing any other communication barrier.
- Have a household telephone.
Who cannot join
- Receiving active treatment for a mood or anxiety disorder from a mental health specialist.
- Unstable medical condition as indicated by history, physical, and/or laboratory findings.
- Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer).
- Organic mood syndromes, including those secondary to medical illness or drugs.
- Active suicidal ideation.
- Current or history of psychotic illness.
Show all 9Show fewer
- Current or history of bipolar illness according to patient self-report, past medical history, and diagnostic criteria.
- Current alcohol or other substance abuse as evidenced by chart review and the AUDIT-C questionnaire.
- Age ≤ 21 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Depression is highly prevalent among patients with heart failure (HF) and associated with lower levels of health-related quality of life and physical functioning, and higher risk of rehospitalization and mortality, and higher health costs. This Project will compare the effectiveness of a "blended" telephone-delivered collaborative care intervention for treating both HF and depression to: (1) collaborative care for HF-alone ("enhanced usual care"; eUC); and (2) doctors' "usual care" for depression (UC). If proven effective and cost-effective, the potentially more powerful, scalable, efficient "blended" care approach for treating HF and co-morbid depression could have profound implications for improving chronic illness care and stimulate development of "blended" interventions for treating other clusters of related medical conditions.
Read the detailed description
Heart failure (HF) is an important public health problem that affects approximately 6.6 million Americans. Despite improvements in cardiac care, it remains the leading cause for hospitalization among Medicare patients and the only major cardiovascular disease whose mortality rate has remained essentially unchanged over the past decade. This failure to improve HF outcomes may be due, in part, to unrecognized and/or inadequately treated depression that is highly prevalent in HF patients. Yet while new HF treatment guidelines advocate routine screening for depression, this recommendation is unlikely to be widely adopted without trial evidence that depression care improves outcomes and efficient methods to provide it.
"Collaborative care" strategies are being increasingly utilized to improve care for HF and other chronic medical conditions, and we recently demonstrated its clinical and cost-effectiveness at treating depression following coronary artery bypass graft surgery. Yet it may be impractical for health care delivery systems to support separate treatment programs for HF and depression. Thus we are encouraged by emerging evidence indicating "blended" collaborative care strategies that target both psychiatric and physical conditions produce greater improvements in mood symptoms and control of cardiovascular risk factors than programs focused solely on depression to propose testing a novel adaptation that could be provided in routine care.
The Specific Aims of this Project are to: (1) evaluate the effectiveness of a telephone-delivered "blended" collaborative care intervention for treating HF and depression that could be adopted into routine clinical practice if proven effective; and (2) advance our understanding of the moderators and mediators of depression treatment on clinical outcomes. We will screen hospitalized patients with systolic HF for depression, and then randomize 625 who screen positive and have at least a moderately elevated level of depressive symptoms at two-weeks following hospital discharge to either: (1) collaborative care for treating both HF and depression ("blended"); (2) collaborative care for treating HF alone (enhanced usual care (eUC)); or (3) their doctors' "usual care" (UC). Additionally, we will enroll 125 non-depressed HF patients to better evaluate the benefits derived from treating depression (total N=750). Our co-primary hypotheses will test whether "blended" collaborative care can produce at 12-months follow-up a: (A) 0.50 effect size (ES) or greater improvement in health-related quality of life (HRQoL) vs. UC; and (B) 0.30 ES or greater improvement in HRQoL vs. eUC. Secondary hypotheses will evaluate the effects of our "blended" intervention on mood, functional status, adherence with guideline-consistent care, incidence of cardiovascular events, health care utilization, and costs.
Improving chronic illness care for medically complex patients is one of the major challenges facing medicine today. We propose to test the effectiveness of an innovative, efficient, scalable, and sustainable intervention that could transform the way HF and other cardiovascular disorders are treated in routine practice.
- Conditions
- Heart Failure, Systolic, Depression, Cardiovascular Disease
- Being tested
- Collaborative Care for Heart Failure, Collaborative Care for Depression
- Keywords
- Heart Failure, Systolic, Depressive Disorder, Depressive Disorder, Major, Mood Disorder
- Medical subject headings
- Heart Failure, Systolic, Depression, Cardiovascular Diseases, Depressive Disorder, Depressive Disorder, Major, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Care for Heart FailureBehavioural
Nurse care managers will provide patients with education for their heart failure to facilitate self-management for their condition. In addition, the nurse will telephone the patient to review with their medical history, medications, diet, activity and sleep patterns, and plans for follow-up medical appointments, and offer basic care coordination relative to heart failure care including assistance attaining authorization for home health services in concert with the patient's primary care physician (PCP), and follow-up appointments.
After case review with a study internist, the care manager may send treatment recommendations to the patient's physician(s) regarding guideline-indicated care. Afterwards, the care manager will telephone the patient approximately every other week to monitor and promote adherence with recommended care, and suggest adjustments in treatment as applicable following discussion with the clinical team and notification of the patient's PCP and cardiologist.
Collaborative Care for DepressionBehavioural
The care manager will telephone patients randomized to "blended" care patient to review their psychiatric history including use of antidepressant pharmacotherapy, herbal supplements, and alcohol possibly used to self-medicate depressive symptoms; provide basic psychoeducation about depression and its impact on cardiac disease; recommend various self-management strategies (e.g., sufficient rest and exercise); and describe treatment options. They will include: (1) use of a workbook or computer program to enhance patients' understanding and ability to self-care; (2) initiation or adjustment of antidepressant pharmacotherapy prescribed under their primary care physicians' direction; or (3) referral to a local mental health specialist. The nurse will then telephone the patient to monitor symptoms and pharmacotherapy use, practice skills imparted through workbook assignments, promote adherence with recommended care, and suggest adjustments in treatment as applicable.
| Study group | Role | What they receive |
|---|---|---|
| Collaborative Care for Heart Failure + Depression | Active comparator | Collaborative care program for heart failure and depression involving a nurse care manager providing counseling and treatment advice via telephone
Interventions:
Behavioral:
Counseling for heart failure self-care Counseling for depression
Drug:
Pharmacotherapy for heart failure Pharmacotherapy for depression Receives: Behavioral: Collaborative Care for Heart Failure; Behavioral: Collaborative Care for Depression |
| Collaborative Care for Heart Failure Only | Active comparator | Collaborative care program for heart failure and depression involving a nurse care manager providing counseling and treatment advice via telephone
Interventions:
Behavioral:
Counseling for heart failure self-care Usual care for depression
Drug:
Pharmacotherapy for heart failure
Usual Care for depression Receives: Behavioral: Collaborative Care for Heart Failure |
| Usual Care for Heart Failure and Depression | No intervention | Control group will receive their doctors' usual care for heart failure and depression |
| Non-Depressed Comparison Cohort | No intervention | Control group will receive their doctors' usual care for heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Outcomes Study (MOS) 12-Item Short Form Health Survey Mental Component Summary (SF-12 MCS)
Mental Health-Related Quality of Life
Measured: 12-Months Follow-Up
Secondary outcomes (6)
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Disease-Specific Health-Related Quality of Life
Measured: 12-Month Follow-Up
Hamilton Rating Scale for Depression (17-Item)
Mood symptoms
Measured: 12-Months Follow-Up
Incidence of Rehospitalization
Measured: 12-Month Follow-Up
Mortality
All-Cause and Cardiovascular Mortality
Measured: 12-Month Follow-Up
Health Care Costs
Claims data
Measured: 12-Month Follow-Up
Employment
Measured: 12-Months Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionOct 2018
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, SystolicStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- "Blended" intervention: Blended, centralized, nurse-provided, telephone-delivered collaborative care for both heart failure and depression; Collaborative care for heart failure: Blended, centralized, nurse-provided, telephone-delivered collaborative care for heart failure alone Usual Care: PCPs usual care for heart failure and depression; and Non-Depressed comparison cohort (randomly sampled, not randomized).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 756 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Bruce Rollman, University of Pittsburgh
- Investigators
- Bruce L. Rollman, MD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044211
- Sponsor's protocol ID
- R01HL114016
- Status last verified
- Aug 2020
- First submitted
- 21 Jan 2014
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Deveney TK, Belnap BH, Mazumdar S, Rollman BL. The prognostic impact and optimal timing of the Patient Health Questionnaire depression screen on 4-year mortality among hospitalized patients with systolic heart failure. Gen Hosp Psychiatry. 2016 Sep-Oct;42:9-14. doi: 10.1016/j.genhosppsych.2016.06.005. Epub 2016 Jun 30.
PubMed 27638965Schuster JM, Belnap BH, Roth LH, Rollman BL. The Checklist Manifesto in action: integrating depression treatment into routine cardiac care. Gen Hosp Psychiatry. 2016 May-Jun;40:1-3. doi: 10.1016/j.genhosppsych.2016.01.005. Epub 2016 Jan 22. No abstract available.
PubMed 26916974Herbeck Belnap B, Anderson A, Abebe KZ, Ramani R, Muldoon MF, Karp JF, Rollman BL. Blended Collaborative Care to Treat Heart Failure and Comorbid Depression: Rationale and Study Design of the Hopeful Heart Trial. Psychosom Med. 2019 Jul/Aug;81(6):495-505. doi: 10.1097/PSY.0000000000000706.
PubMed 31083056Rollman BL. Exercise and Cognitive Training to Improve Neurocognitive Outcomes in Patients With Heart Failure: Can Cardiac Rehabilitation Deliver? Am J Geriatr Psychiatry. 2019 Aug;27(8):820-822. doi: 10.1016/j.jagp.2019.05.001. Epub 2019 May 6. No abstract available.
PubMed 31151835Bober T, Guhl EN, Rothenberger S, Jeong K, Abebe KZ, Holber J, Anderson AM, Magnani JW, Johnson AE, Rollman BL. Impact of Neighborhood Factors on Heart Failure Outcomes: Secondary Analysis From the Hopeful Heart Trial. JACC Adv. 2025 Oct;4(10 Pt 2):102146. doi: 10.1016/j.jacadv.2025.102146. Epub 2025 Sep 14.
PubMed 40953541Carrillo A, Belnap BH, Rothenberger SD, Feldman R, Rollman BL, Celano CM. Psychosocial predictors of health behavior adherence in heart-failure patients with comorbid depression: a secondary analysis of the Hopeful Heart trial. BMC Psychol. 2024 Jun 4;12(1):328. doi: 10.1186/s40359-024-01816-4.
PubMed 38835104Sadlonova M, Chavanon ML, Kwonho J, Abebe KZ, Celano CM, Huffman J, Herbeck Belnap B, Rollman BL. Depression Subtypes in Systolic Heart Failure: A Secondary Analysis From a Randomized Controlled Trial. J Acad Consult Liaison Psychiatry. 2023 Sep-Oct;64(5):444-456. doi: 10.1016/j.jaclp.2023.03.008. Epub 2023 Mar 29.
PubMed 37001642Holber JP, Abebe KZ, Huang Y, Jakicic JM, Anderson AM, Belnap BH, Rollman BL. The Relationship Between Objectively Measured Step Count, Clinical Characteristics, and Quality of Life Among Depressed Patients Recently Hospitalized With Systolic Heart Failure. Psychosom Med. 2022 Feb-Mar 01;84(2):231-236. doi: 10.1097/PSY.0000000000001034.
PubMed 34724453Rollman BL, Anderson AM, Rothenberger SD, Abebe KZ, Ramani R, Muldoon MF, Jakicic JM, Herbeck Belnap B, Karp JF. Efficacy of Blended Collaborative Care for Patients With Heart Failure and Comorbid Depression: A Randomized Clinical Trial. JAMA Intern Med. 2021 Oct 1;181(10):1369-1380. doi: 10.1001/jamainternmed.2021.4978.
PubMed 34459842
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blended Collaborative Care for Heart Failure and Co-Morbid Depression
- ClinicalTrials.gov ID
- NCT02044211
- Acronym / sponsor ID
- R01HL114016
- Conditions
- Heart Failure, Systolic, Depression, Cardiovascular Disease
- Keywords
- Heart Failure, Systolic, Depressive Disorder, Depressive Disorder, Major, Mood Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 756 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2014 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 23 Jan 2014 (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.
Depression is highly prevalent among patients with heart failure (HF) and associated with lower levels of health-related quality of life and physical functioning, and higher risk of rehospitalization and mortality, and higher health costs. This Project will compare the effectiveness of a "blended" telephone-delivered collaborative care intervention for treating both HF and depression to: (1) collaborative care for HF-alone ("enhanced usual care"; eUC); and (2) doctors' "usual care" for depression (UC). If proven effective and cost-effective, the potentially more powerful, scalable, efficient "blended" care approach for treating HF and co-morbid depression could have profound implications for improving chronic illness care and stimulate development of "blended" interventions for treating other clusters of related medical conditions.
Detailed description
Heart failure (HF) is an important public health problem that affects approximately 6.6 million Americans. Despite improvements in cardiac care, it remains the leading cause for hospitalization among Medicare patients and the only major cardiovascular disease whose mortality rate has remained essentially unchanged over the past decade. This failure to improve HF outcomes may be due, in part, to unrecognized and/or inadequately treated depression that is highly prevalent in HF patients. Yet while new HF treatment guidelines advocate routine screening for depression, this recommendation is unlikely to be widely adopted without trial evidence that depression care improves outcomes and efficient methods to provide it.
"Collaborative care" strategies are being increasingly utilized to improve care for HF and other chronic medical conditions, and we recently demonstrated its clinical and cost-effectiveness at treating depression following coronary artery bypass graft surgery. Yet it may be impractical for health care delivery systems to support separate treatment programs for HF and depression. Thus we are encouraged by emerging evidence indicating "blended" collaborative care strategies that target both psychiatric and physical conditions produce greater improvements in mood symptoms and control of cardiovascular risk factors than programs focused solely on depression to propose testing a novel adaptation that could be provided in routine care.
The Specific Aims of this Project are to: (1) evaluate the effectiveness of a telephone-delivered "blended" collaborative care intervention for treating HF and depression that could be adopted into routine clinical practice if proven effective; and (2) advance our understanding of the moderators and mediators of depression treatment on clinical outcomes. We will screen hospitalized patients with systolic HF for depression, and then randomize 625 who screen positive and have at least a moderately elevated level of depressive symptoms at two-weeks following hospital discharge to either: (1) collaborative care for treating both HF and depression ("blended"); (2) collaborative care for treating HF alone (enhanced usual care (eUC)); or (3) their doctors' "usual care" (UC). Additionally, we will enroll 125 non-depressed HF patients to better evaluate the benefits derived from treating depression (total N=750). Our co-primary hypotheses will test whether "blended" collaborative care can produce at 12-months follow-up a: (A) 0.50 effect size (ES) or greater improvement in health-related quality of life (HRQoL) vs. UC; and (B) 0.30 ES or greater improvement in HRQoL vs. eUC. Secondary hypotheses will evaluate the effects of our "blended" intervention on mood, functional status, adherence with guideline-consistent care, incidence of cardiovascular events, health care utilization, and costs.
Improving chronic illness care for medically complex patients is one of the major challenges facing medicine today. We propose to test the effectiveness of an innovative, efficient, scalable, and sustainable intervention that could transform the way HF and other cardiovascular disorders are treated in routine practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- "Blended" intervention: Blended, centralized, nurse-provided, telephone-delivered collaborative care for both heart failure and depression; Collaborative care for heart failure: Blended, centralized, nurse-provided, telephone-delivered collaborative care for heart failure alone Usual Care: PCPs usual care for heart failure and depression; and Non-Depressed comparison cohort (randomly sampled, not randomized).
| Arm | Type | Receives |
|---|---|---|
| Collaborative Care for Heart Failure + Depression | Active comparator | Behavioral: Collaborative Care for Heart Failure, Behavioral: Collaborative Care for DepressionCollaborative care program for heart failure and depression involving a nurse care manager providing counseling and treatment advice via telephone Interventions: Behavioral: Counseling for heart failure self-care Counseling for depression Drug: Pharmacotherapy for heart failure Pharmacotherapy for depression |
| Collaborative Care for Heart Failure Only | Active comparator | Behavioral: Collaborative Care for Heart FailureCollaborative care program for heart failure and depression involving a nurse care manager providing counseling and treatment advice via telephone Interventions: Behavioral: Counseling for heart failure self-care Usual care for depression Drug: Pharmacotherapy for heart failure Usual Care for depression |
| Usual Care for Heart Failure and Depression | No intervention | –Control group will receive their doctors' usual care for heart failure and depression |
| Non-Depressed Comparison Cohort | No intervention | –Control group will receive their doctors' usual care for heart failure |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Systolic heart failure (documented ejection fraction ≤ 40%).
- HF symptoms meeting criteria for New York Heart Association (NYHA) classes II, III or IV.
- Inpatient two-item Patient Health Questionnaire (PHQ-2) screen-positive for depression; or PHQ-2 screen negative for depression and PHQ-9 <5 if non-depressed control.
- PHQ-9 ≥ 10 when reassessed two-weeks following hospital discharge, or PHQ-9 <5 if non-depressed control.
- No cognitive impairment (as documented in the record, use of donepezil or similar medications for treating cognitive impairment, or the Montreal Cognitive Assessment).
Key exclusion criteria (9 listed)
- Receiving active treatment for a mood or anxiety disorder from a mental health specialist.
- Unstable medical condition as indicated by history, physical, and/or laboratory findings.
- Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer).
- Organic mood syndromes, including those secondary to medical illness or drugs.
- Active suicidal ideation.
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 |
|---|---|---|
| Collaborative Care for Heart FailureNurse care managers will provide patients with education for their heart failure to facilitate self-management for their condition. In addition, the nurse will telephone the patient to review with their medical history, medications, diet, activity and sleep patterns, and plans for follow-up medical appointments, and offer basic care coordination relative to heart failure care including assistance attaining authorization for home health services in concert with the patient's primary care physician (PCP), and follow-up appointments. After case review with a study internist, the care manager may send treatment recommendations to the patient's physician(s) regarding guideline-indicated care. Afterwards, the care manager will telephone the patient approximately every other week to monitor and promote adherence with recommended care, and suggest adjustments in treatment as applicable following discussion with the clinical team and notification of the patient's PCP and cardiologist. | Behavioural | Collaborative Care for Heart Failure + Depression, Collaborative Care for Heart Failure Only |
| Collaborative Care for DepressionThe care manager will telephone patients randomized to "blended" care patient to review their psychiatric history including use of antidepressant pharmacotherapy, herbal supplements, and alcohol possibly used to self-medicate depressive symptoms; provide basic psychoeducation about depression and its impact on cardiac disease; recommend various self-management strategies (e.g., sufficient rest and exercise); and describe treatment options. They will include: (1) use of a workbook or computer program to enhance patients' understanding and ability to self-care; (2) initiation or adjustment of antidepressant pharmacotherapy prescribed under their primary care physicians' direction; or (3) referral to a local mental health specialist. The nurse will then telephone the patient to monitor symptoms and pharmacotherapy use, practice skills imparted through workbook assignments, promote adherence with recommended care, and suggest adjustments in treatment as applicable. | Behavioural | Collaborative Care for Heart Failure + Depression |
Primary outcome
Medical Outcomes Study (MOS) 12-Item Short Form Health Survey Mental Component Summary (SF-12 MCS)
Time frame: 12-Months Follow-Up
Mental Health-Related Quality of Life
6 secondary outcomes
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time frame: 12-Month Follow-Up
Hamilton Rating Scale for Depression (17-Item)
Time frame: 12-Months Follow-Up
Incidence of Rehospitalization
Time frame: 12-Month Follow-Up
Mortality
Time frame: 12-Month Follow-Up
Health Care Costs
Time frame: 12-Month Follow-Up
Employment
Time frame: 12-Months Follow-Up
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 Aug 2020.
- Background: PubMed 27638965Deveney TK, Belnap BH, Mazumdar S, Rollman BL. The prognostic impact and optimal timing of the Patient Health Questionnaire depression screen on 4-year mortality among hospitalized patients with systolic heart failure. Gen Hosp Psychiatry. 2016 Sep-Oct;42:9-14. doi: 10.1016/j.genhosppsych.2016.06.005. Epub 2016 Jun 30.
- Background: PubMed 26916974Schuster JM, Belnap BH, Roth LH, Rollman BL. The Checklist Manifesto in action: integrating depression treatment into routine cardiac care. Gen Hosp Psychiatry. 2016 May-Jun;40:1-3. doi: 10.1016/j.genhosppsych.2016.01.005. Epub 2016 Jan 22. No abstract available.
- Background: PubMed 31083056Herbeck Belnap B, Anderson A, Abebe KZ, Ramani R, Muldoon MF, Karp JF, Rollman BL. Blended Collaborative Care to Treat Heart Failure and Comorbid Depression: Rationale and Study Design of the Hopeful Heart Trial. Psychosom Med. 2019 Jul/Aug;81(6):495-505. doi: 10.1097/PSY.0000000000000706.
- Background: PubMed 31151835Rollman BL. Exercise and Cognitive Training to Improve Neurocognitive Outcomes in Patients With Heart Failure: Can Cardiac Rehabilitation Deliver? Am J Geriatr Psychiatry. 2019 Aug;27(8):820-822. doi: 10.1016/j.jagp.2019.05.001. Epub 2019 May 6. No abstract available.
- Derived from this study: PubMed 40953541Bober T, Guhl EN, Rothenberger S, Jeong K, Abebe KZ, Holber J, Anderson AM, Magnani JW, Johnson AE, Rollman BL. Impact of Neighborhood Factors on Heart Failure Outcomes: Secondary Analysis From the Hopeful Heart Trial. JACC Adv. 2025 Oct;4(10 Pt 2):102146. doi: 10.1016/j.jacadv.2025.102146. Epub 2025 Sep 14.
- Derived from this study: PubMed 38835104Carrillo A, Belnap BH, Rothenberger SD, Feldman R, Rollman BL, Celano CM. Psychosocial predictors of health behavior adherence in heart-failure patients with comorbid depression: a secondary analysis of the Hopeful Heart trial. BMC Psychol. 2024 Jun 4;12(1):328. doi: 10.1186/s40359-024-01816-4.
- Derived from this study: PubMed 37001642Sadlonova M, Chavanon ML, Kwonho J, Abebe KZ, Celano CM, Huffman J, Herbeck Belnap B, Rollman BL. Depression Subtypes in Systolic Heart Failure: A Secondary Analysis From a Randomized Controlled Trial. J Acad Consult Liaison Psychiatry. 2023 Sep-Oct;64(5):444-456. doi: 10.1016/j.jaclp.2023.03.008. Epub 2023 Mar 29.
- Derived from this study: PubMed 34724453Holber JP, Abebe KZ, Huang Y, Jakicic JM, Anderson AM, Belnap BH, Rollman BL. The Relationship Between Objectively Measured Step Count, Clinical Characteristics, and Quality of Life Among Depressed Patients Recently Hospitalized With Systolic Heart Failure. Psychosom Med. 2022 Feb-Mar 01;84(2):231-236. doi: 10.1097/PSY.0000000000001034.
- Derived from this study: PubMed 34459842Rollman BL, Anderson AM, Rothenberger SD, Abebe KZ, Ramani R, Muldoon MF, Jakicic JM, Herbeck Belnap B, Karp JF. Efficacy of Blended Collaborative Care for Patients With Heart Failure and Comorbid Depression: A Randomized Clinical Trial. JAMA Intern Med. 2021 Oct 1;181(10):1369-1380. doi: 10.1001/jamainternmed.2021.4978.
- Center for Research on Health CareLink provided by the sponsor.
- Related trial of collaborative care for treating depression following coronary artery bypass graft (CABG) surgeryLink provided by the sponsor.
- Center for Behavioral Health and Smart TechnologyLink provided by the sponsor.
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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.
Bruce L. Rollman, MD, MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Collaborative Care for Heart Failure and Collaborative Care for Depression in people with Heart Failure, Systolic and Depression, run by University of Pittsburgh 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 8 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 5 Aug 2020. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Medical Outcomes Study (MOS) 12-Item Short Form Health Survey Mental Component Summary (SF-12 MCS) (time frame: 12-Months Follow-Up). 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 NCT02044211, which also lists 9 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 5 Aug 2020.