Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT05337293
Status:
COMPLETED
Last Update Posted:
2023-03-21
First Post:
2022-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Coping in Heart Failure Partnership Intervention
Sponsor:
Florida State University
Organization:
Study Overview
Official Title:
Coping in Heart Failure Partnership (COPE-HF): A Telephone-Based Intervention Study
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPE-HF
Brief Summary:
The purpose of this study is to examine the feasibility and preliminary effectiveness of a 12-week support and problem-solving telephone-based intervention (COPE-HF) on heart failure self-care, depression, and healthcare utilization. Heart failure patients will be randomized to one of three groups (intervention, attention, control), with data collected at baseline and at 5, 9, and 13 weeks.
Detailed Description:
The long-term goal of this research is to reduce morbidity and improve heart failure self-care and depression in heart failure patients. The initial step in meeting this goal is to pilot-test a telephone-based, tailored support and problem-solving intervention (COPE-HF Partnership) to improve HF self-care and depression in a sample of heart failure patients. The following research aims are to: 1) test the COPE-HF Partnership intervention and determine its feasibility and acceptability for managing HF-related problems; and 2) evaluate the preliminary effects of the COPE-HF Partnership intervention on heart failure self-care, depression, and healthcare utilization. This study will be guided by quantitative methods and include a repeated measures, randomized controlled trial to evaluate the feasibility, acceptability, and preliminary effectiveness of the 12-week COPE-Partnership intervention in a sample of heart failure patients (n = 90). Participants for this study will be recruited from from the cardiac/telemetry floors at Tallahassee Memorial Hospital and Capital Regional Medical Center in Tallahassee, FL.
The target recruitment size was 90 participants based upon attrition rates reported in previous studies (35%) and the number of participants needed to provide trend data in preparation for a larger, more adequately powered clinical trial. Following verbal informed consent, all participants were screened for cognitive impairment using the 6 Item Cognitive Impairment Test (6CIT) prior to baseline data collection. Data were collected using the following instruments: a Sociodemographic and Clinical Survey (baseline only), the Self-Care of HF Index (SCHFI; v. 6.2), the Heart Failure Symptom Survey (HFSS), the Interpersonal Support Evaluation List-12 (ISEL-12), the Social Problem-Solving Inventory Revised (SPSIR), Healthcare Utilization Survey, the Center for Epidemiological Studies-Depression (CESD), the Family APGAR.
Participants randomized to the intervention group participated in a telephone-based support and problem-solving training intervention over 12 weeks (Weeks 1-4, 6, 8, 10, 12).
Participants randomized to the attention group received usual care plus telephone calls on the same schedule as the intervention group and consisted of a health check with information collected regarding recent healthcare usage.
Participants randomized to the control group received usual care from their healthcare providers and received heart failure self-care education upon discharge from the healthcare facility.
Follow-up data collection occurred at weeks 5, 9, 11, 13. All data were self-report and collected by a trained research assistant who collected study data over the telephone and marked participants answers on a computerized data spreadsheet. Data were analyzed using linear and multi-level modeling approaches.
The target recruitment size was 90 participants based upon attrition rates reported in previous studies (35%) and the number of participants needed to provide trend data in preparation for a larger, more adequately powered clinical trial. Following verbal informed consent, all participants were screened for cognitive impairment using the 6 Item Cognitive Impairment Test (6CIT) prior to baseline data collection. Data were collected using the following instruments: a Sociodemographic and Clinical Survey (baseline only), the Self-Care of HF Index (SCHFI; v. 6.2), the Heart Failure Symptom Survey (HFSS), the Interpersonal Support Evaluation List-12 (ISEL-12), the Social Problem-Solving Inventory Revised (SPSIR), Healthcare Utilization Survey, the Center for Epidemiological Studies-Depression (CESD), the Family APGAR.
Participants randomized to the intervention group participated in a telephone-based support and problem-solving training intervention over 12 weeks (Weeks 1-4, 6, 8, 10, 12).
Participants randomized to the attention group received usual care plus telephone calls on the same schedule as the intervention group and consisted of a health check with information collected regarding recent healthcare usage.
Participants randomized to the control group received usual care from their healthcare providers and received heart failure self-care education upon discharge from the healthcare facility.
Follow-up data collection occurred at weeks 5, 9, 11, 13. All data were self-report and collected by a trained research assistant who collected study data over the telephone and marked participants answers on a computerized data spreadsheet. Data were analyzed using linear and multi-level modeling approaches.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: