Clinical trial NCT03606304: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Depression
Keywords: self-care
quality of life
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. age ≥ 65;
2. having a primary diagnosis of HF (New York Heart Association \[NYHA\] Class I, II, III) of the index hospitalization;
3. having clinically significant depressive symptoms (PHQ-9 score≥10) at both hospital discharge and four weeks after hospital discharge;
4. inadequate HF self-care ability (any domain score in the Self-Care of Heart Failure Index \[SCHFI\]≤70/100); and
5. having normal or mildly impaired cognitive function (score of Montreal Cognitive Assessment \[MoCA\]: 23-30).

Exclusion Criteria:

1. being listed for an implanted ventricular assist device, heart transplant or currently receiving Milrinone infusion (indicating decompensated HF);
2. receiving hospice care or end-of-life care;
3. 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);
4. initiation or titration of antidepressants in the past 8 weeks; or
5. inability to give informed consent and/or to communicate verbally in English.

Primary outcomes:
measure: Problem-solving skills
timeFrame: 6 months post-discharge
Secondary outcomes:
measure: Behavioral Activation for Depression
timeFrame: 6 months post-discharge
measure: Depressive symptoms
timeFrame: 6 months post-discharge
measure: Depressive symptoms
timeFrame: 6 months post-discharge
measure: Heart Failure Self-care
timeFrame: 6 months post-discharge
Other outcomes:
Locations:
Study officials:
affiliation: University of Rochester
name: Tiffany Gommel, MS, CIM, CIP
role: STUDY_DIRECTOR
References: