Ignite Creation Date:
2024-05-06 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05337293
Status:
COMPLETED
Last Update Posted:
2023-03-21
First Post:
2022-04-13
Brief Title:
Coping in Heart Failure Partnership Intervention
Sponsor:
Florida State University
Organization:
Florida State University
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 cardiactelemetry 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 62 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 62 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:
None
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?:
None