Problem-solving to Improve Depressive Symptoms and Self- Care Among Recently Hospitalized Adults With Heart Failure
Primary Purpose
Heart Failure, Depression
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Problem-solving therapy
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring self-care, quality of life
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Problem-solving therapy
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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"
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03606304
Brief Title
Problem-solving to Improve Depressive Symptoms and Self- Care Among Recently Hospitalized Adults With Heart Failure
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Withdrawn
Why Stopped
The study was not deemed feasible to conduct.
Study Start Date
May 2019 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Depression
Keywords
self-care, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Problem-solving therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Problem-solving therapy
Intervention Description
See previous
Primary Outcome Measure Information:
Title
Problem-solving skills
Description
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.
Time Frame
6 months post-discharge
Secondary Outcome Measure Information:
Title
Behavioral Activation for Depression
Description
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.
Time Frame
6 months post-discharge
Title
Depressive symptoms
Description
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
Time Frame
6 months post-discharge
Title
Depressive symptoms
Description
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"
Time Frame
6 months post-discharge
Title
Heart Failure Self-care
Description
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.
Time Frame
6 months post-discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany Gommel, MS, CIM, CIP
Organizational Affiliation
University of Rochester
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
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Problem-solving to Improve Depressive Symptoms and Self- Care Among Recently Hospitalized Adults With Heart Failure
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