Heart FailureNCT03606304
Problem-solving to Improve Depressive Symptoms and Self- Care Among Recently Hospitalized Adults With Heart Failure
A study testing Problem-solving therapy in people with Heart Failure and Depression, run by University of Rochester.
Trial summary
The purpose of this study is to examine the feasibility of providing a problem-solving therapy-based intervention to improve both depressive symptoms and heart failure self-care specifically after hospital discharge. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure, Depression
- What is being tested?
- Problem-solving therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2019to Dec 2019
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age ≥ 65;
- having a primary diagnosis of HF (New York Heart Association [NYHA] Class I, II, III) of the index hospitalization;
- having clinically significant depressive symptoms (PHQ-9 score≥10) at both hospital discharge and four weeks after hospital discharge;
- inadequate HF self-care ability (any domain score in the Self-Care of Heart Failure Index [SCHFI]≤70/100); and
- having normal or mildly impaired cognitive function (score of Montreal Cognitive Assessment [MoCA]: 23-30).
Who cannot join
- being listed for an implanted ventricular assist device, heart transplant or currently receiving Milrinone infusion (indicating decompensated HF);
- receiving hospice care or end-of-life care;
- having diagnoses of the following, a) delirium or advanced Alzheimer's disease, b) malignant cancer, coronary artery disease requiring surgery or angioplasty, renal disease on dialysis in the present or within the past two years, c) severe psychotic disorder or suicidal ideation (or scored "0" in PHQ-9 item #9);
- initiation or titration of antidepressants in the past 8 weeks; or
- inability to give informed consent and/or to communicate verbally in English.
About this study
Official title: Using Problem-solving Intervention (PST-HF) to Improve Depressive Symptoms and Self- Care Ability Among Recently Hospitalized Older Patients With Heart Failure: A Feasibility Study
The purpose of this study is to examine the feasibility of providing a problem-solving therapy-based intervention to improve both depressive symptoms and heart failure self-care specifically after hospital discharge. This is because the period after hospital discharge is critical to long-term recovery, overall quality of life, and prevention of adverse outcomes, such as hospital readmission.
Read the detailed description
Depressive symptoms and impaired self-care respectively occur in up to 58% and 80% of older hospitalized patients with heart failure, and each doubles the risk of rehospitalization. These two conditions are closely intertwined with shared core behaviors/experiences, i.e., hopelessness/negative expectation, loss of motivation, impaired problem-solving skills, and social isolation/poor social support. As such, integrated interventions that explicitly address both depressive symptoms and impaired HF self-care are more efficacious than interventions that focus on depressive symptoms or HF self-care alone. In separate studies, problem-solving therapy (PST) has been effective to improve depressive symptoms and self-care for heart disease in older adults, including those with mild cognitive impairment. Though promising, there is no evidence regarding PST efficacy in addressing both depressive symptoms and self-care in HF patients. This is due to 1) sample heterogeneity, as only 18% to 77% of the subjects in prior studies had HF, and 2) separate interventional foci, as HF information was not used to link depressed mood to impaired self-care. Characteristics of hospitalized HF patients such as timing and cognitive function were also not considered. The first three months after hospital discharge is the period when depressive symptoms are most likely to change and when impaired HF self-care is mostly likely to lead to rehospitalization. Moreover, more than half (54%) of older depressed HF patients have mild cognitive impairment that can lead to dementia, especially in the context of impaired self-care, uncontrolled HF and restricted cerebral blood flow. However, no PST interventions have been specifically provided in the post-discharge period or among HF patients with mild cognitive impairment. To date, there is no evidence regarding the efficacy of integrated PST interventions on both depressive symptoms and impaired self-care in HF patients after hospital discharge.
The ultimate goal of this research program is to prevent rehospitalization in HF patients using integrated PST interventions to simultaneously improve depressive symptoms and self-care. Built on the investigator's prior work with depressive symptoms in home health care (HHC), this study will examine the feasibility of a home-based, telephone-enhanced PST intervention (PST-HF) in these patients after hospital discharge.
- Conditions
- Heart Failure, Depression
- Being tested
- Problem-solving therapy
- Keywords
- self-care, quality of life
- 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.
Problem-solving therapyBehavioural
See previous
| Study group | Role | What they receive |
|---|---|---|
| Problem-solving therapy | Experimental | The intervention is based on an established PST protocol for medical patients, with an additional focus on HF to link depressed mood to impaired HF self-care. Seven steps are included: 1) select and define the problem; 2) establish realistic and achievable goals for problem resolutions; 3) generate multiple solution alternatives (brainstorming); 4) implement decision-making guidelines (pros and cons); 5) evaluate and choose the solutions; 6) implement the preferred solution(s); and 7) evaluate the outcome. Receives: Behavioral: Problem-solving therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Problem-solving skills
problem solving skills as measured by the Social Problem-Solving Inventory-Revised (Short) SPSI-R:S: There are 25 items measuring 5 components: Positive Problem Orientation, Negative Problem Orientation, Rational Problem Solving, Impulsivity/Carelessness Style, and Avoidance Style. Validated norms are provided by age group and raw scores are plotted for conversion to standard scores. Higher scores reflect greater intensity of the construct measured.
Measured: 6 months post-discharge
Secondary outcomes (4)
Behavioral Activation for Depression
Behavioral activation as measured by the Behavioral Activation for Depression Scale-Short Form (BADS-SF): ( item instrument with scores ranging from 0=not at all to 6=completely. Item scores are summed and higher scores indicate increased activation.
Measured: 6 months post-discharge
Depressive symptoms
Depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9): 9 items with item anchors of 0=Not at all to 3=nearly every day; scale scores range from 0-27 with higher scores indicating greater depressive symptoms
Measured: 6 months post-discharge
Depressive symptoms
Depressive symptoms as measured by the Hamilton Depression Rating Scale (HAM-D): Scores are based on 17 items with higher scores indicative or higher depressive symptoms. Scores 0-7 are classified as "normal"; 8-13="mild depression"; 14-18="moderate depression"; 19-22="severe depression; and >=23="very severe depression"
Measured: 6 months post-discharge
Heart Failure Self-care
Heart failure self-care as measured by the Self-Care of Heart Failure Index (SCHFI): There are 3 scales: Self-Care Maintenance, Self-Care Management, and Self-Care Confidence. Self-Care Maintenance (10 items) assess self-care behaviors and each item is scored from 1=Never/rarely to 4=Always/daily. The Self-Care Management scale has 7 items. Item #11 is scored from 0=I did not recognize it to 4=Very quickly; item #s12-15 are scored from 1=Not likely to 4=Very likely; and item #16 is scored from 0=I did not try anything to 4=Very sure. The Self-Care Confidence scale has 6 items scored from 1=not confident to 4=extremely confident. All scales scores are standardized yileding scores ranging from 0 to 100.
Measured: 6 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study startMay 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: The study was not deemed feasible to conduct.
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single group, pre-/post-test design with a 6 month follow-up period. There are 8 weekly intervention sessions, each approximately 30-45 minutes long. The 3 telephone booster sessions occurring every two months during the followup phase are estimated to last 20 minutes.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinjiao Wang, University of Rochester
- Investigators
- Tiffany Gommel, MS, CIM, CIP, Study director, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606304
- Sponsor's protocol ID
- SON2018-002
- Status last verified
- Jul 2019
- First submitted
- 17 Jul 2018
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Problem-solving Intervention (PST-HF) to Improve Depressive Symptoms and Self- Care Ability Among Recently Hospitalized Older Patients With Heart Failure: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03606304
- Acronym / sponsor ID
- SON2018-002
- Conditions
- Heart Failure, Depression
- Keywords
- self-care, quality of life
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not deemed feasible to conduct.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 30 Jul 2018 (actual)
- 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 examine the feasibility of providing a problem-solving therapy-based intervention to improve both depressive symptoms and heart failure self-care specifically after hospital discharge. This is because the period after hospital discharge is critical to long-term recovery, overall quality of life, and prevention of adverse outcomes, such as hospital readmission.
Detailed description
Depressive symptoms and impaired self-care respectively occur in up to 58% and 80% of older hospitalized patients with heart failure, and each doubles the risk of rehospitalization. These two conditions are closely intertwined with shared core behaviors/experiences, i.e., hopelessness/negative expectation, loss of motivation, impaired problem-solving skills, and social isolation/poor social support. As such, integrated interventions that explicitly address both depressive symptoms and impaired HF self-care are more efficacious than interventions that focus on depressive symptoms or HF self-care alone. In separate studies, problem-solving therapy (PST) has been effective to improve depressive symptoms and self-care for heart disease in older adults, including those with mild cognitive impairment. Though promising, there is no evidence regarding PST efficacy in addressing both depressive symptoms and self-care in HF patients. This is due to 1) sample heterogeneity, as only 18% to 77% of the subjects in prior studies had HF, and 2) separate interventional foci, as HF information was not used to link depressed mood to impaired self-care. Characteristics of hospitalized HF patients such as timing and cognitive function were also not considered. The first three months after hospital discharge is the period when depressive symptoms are most likely to change and when impaired HF self-care is mostly likely to lead to rehospitalization. Moreover, more than half (54%) of older depressed HF patients have mild cognitive impairment that can lead to dementia, especially in the context of impaired self-care, uncontrolled HF and restricted cerebral blood flow. However, no PST interventions have been specifically provided in the post-discharge period or among HF patients with mild cognitive impairment. To date, there is no evidence regarding the efficacy of integrated PST interventions on both depressive symptoms and impaired self-care in HF patients after hospital discharge.
The ultimate goal of this research program is to prevent rehospitalization in HF patients using integrated PST interventions to simultaneously improve depressive symptoms and self-care. Built on the investigator's prior work with depressive symptoms in home health care (HHC), this study will examine the feasibility of a home-based, telephone-enhanced PST intervention (PST-HF) in these patients after hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single group, pre-/post-test design with a 6 month follow-up period. There are 8 weekly intervention sessions, each approximately 30-45 minutes long. The 3 telephone booster sessions occurring every two months during the followup phase are estimated to last 20 minutes.
| Arm | Type | Receives |
|---|---|---|
| Problem-solving therapy | Experimental | Behavioral: Problem-solving therapyThe intervention is based on an established PST protocol for medical patients, with an additional focus on HF to link depressed mood to impaired HF self-care. Seven steps are included: 1) select and define the problem; 2) establish realistic and achievable goals for problem resolutions; 3) generate multiple solution alternatives (brainstorming); 4) implement decision-making guidelines (pros and cons); 5) evaluate and choose the solutions; 6) implement the preferred solution(s); and 7) evaluate the outcome. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- age ≥ 65;
- having a primary diagnosis of HF (New York Heart Association [NYHA] Class I, II, III) of the index hospitalization;
- having clinically significant depressive symptoms (PHQ-9 score≥10) at both hospital discharge and four weeks after hospital discharge;
- inadequate HF self-care ability (any domain score in the Self-Care of Heart Failure Index [SCHFI]≤70/100); and
- having normal or mildly impaired cognitive function (score of Montreal Cognitive Assessment [MoCA]: 23-30).
Key exclusion criteria (5 listed)
- being listed for an implanted ventricular assist device, heart transplant or currently receiving Milrinone infusion (indicating decompensated HF);
- receiving hospice care or end-of-life care;
- having diagnoses of the following, a) delirium or advanced Alzheimer's disease, b) malignant cancer, coronary artery disease requiring surgery or angioplasty, renal disease on dialysis in the present or within the past two years, c) severe psychotic disorder or suicidal ideation (or scored "0" in PHQ-9 item #9);
- initiation or titration of antidepressants in the past 8 weeks; or
- inability to give informed consent and/or to communicate verbally in English.
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 |
|---|---|---|
| Problem-solving therapySee previous | Behavioural | Problem-solving therapy |
Primary outcome
Problem-solving skills
Time frame: 6 months post-discharge
problem solving skills as measured by the Social Problem-Solving Inventory-Revised (Short) SPSI-R:S: There are 25 items measuring 5 components: Positive Problem Orientation, Negative Problem Orientation, Rational Problem Solving, Impulsivity/Carelessness Style, and Avoidance Style. Validated norms are provided by age group and raw scores are plotted for conversion to standard scores. Higher scores reflect greater intensity of the construct measured.
4 secondary outcomes
Behavioral Activation for Depression
Time frame: 6 months post-discharge
Depressive symptoms
Time frame: 6 months post-discharge
Depressive symptoms
Time frame: 6 months post-discharge
Heart Failure Self-care
Time frame: 6 months post-discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
Active, not recruiting
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
Heart Failure, Congestive Heart Failure
Active, not recruiting
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction, Concentric Hypertrophy
Recruiting
Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
HFrEF - Heart Failure With Reduced Ejection Fraction
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
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.
Tiffany Gommel, MS, CIM, CIP study director
University of Rochester
Questions about this trial
What is this clinical trial studying?
A study testing Problem-solving therapy in people with Heart Failure and Depression, run by University of Rochester.
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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 8 Jul 2019. 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. 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 withdrawn before enrolling participants, so there are no results.
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?
Problem-solving skills (time frame: 6 months post-discharge). 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 8 Jul 2019; AzTrials last refreshed its copy on 29 Oct 2026.