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Behavioral Intervention

Phase II: Problem-Solving for Rural HF Dyads for Heart Failure

N/A

Waitlist Available

Research Sponsored by Florida State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline,13 weeks

Awards & highlights

Study Summary

This trial will develop and test an intervention to improve self-care in rural heart failure patients and their caregivers. The intervention will be delivered via telephone or virtual session, and will include follow-up telephone sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline,13 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline,13 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline,13 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Caregiver Contribution to Self-Care Confidence (caregiver)

Caregiver Contribution to Self-Care Maintenance (caregiver)

Caregiver Contribution to Self-Care Management (caregiver)

+3 more

Secondary outcome measures

Healthcare Utilization (patient)

Problem-Solving (HF patient and caregiver)

Other outcome measures

Caregiver Burden (caregiver)

Caregiver Self-care (caregiver)

Depression (patient and caregiver)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Phase II: Problem-Solving for Rural HF DyadsExperimental Treatment1 Intervention

The dyadic problem-solving intervention will be provided by a HF specialist nurse. The nurse will conduct the initial telehealth (virtual, telephone) session and provide dyads with an intervention booklet containing examples of common HF-related problems experienced by rural dyads and suggested management strategies tailored to the rural sociocultural context. The nurse will lead dyads in a card sorting task intended to help dyads prioritize current HF-related problems and will guide dyads in developing management strategies for the highest priority problem. Dyads will utilize these strategies until the next session at which time the nurse will guide dyads in evaluating the effectiveness of chosen strategies. The iterative process then begins again. Dyads will receive 7 follow-up telephone sessions with the nurse. In the intervention, the nurse will focus on problems related to self-care, including those specific to the rural population.

Group II: Phase I: QualitativeActive Control1 Intervention

Rural HF dyads will participate in a one-time telephone-based semi-structured interview to explore the types of HF-related problems that rural HF dyads experience and how these problems are managed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Phase II: Problem-Solving for Rural HF Dyads

2020

N/A

~100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Florida State UniversityLead Sponsor

199 Previous Clinical Trials

31,597 Total Patients Enrolled

2 Trials studying Heart Failure

206 Patients Enrolled for Heart Failure

Florida Blue Center for Rural ResearchUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individual participants can be accepted into this clinical research?

"Affirmative. The information found on clinicaltrials.gov indicates that the application process is still open, having been first uploaded to the website on September 29th 2020 and most recently updated June 15th 2022. Approximately 160 individuals must be recruited from 9 locations for this study."

Answered by AI

Are medical professionals currently recruiting for this trial?

"According to the details found on clinicaltrials.gov, recruiting for this medical trial is ongoing. The study was first posted on September 29th 2020 and latest changes were done June 15th 2022."

Answered by AI

How many venues are administering this research project?

"Nine clinical trial sites have been commissioned for this medical investigation. These include Tallahassee Memorial Hospital Physician Partners - Quincy Clinic in Quincy, Tallahassee Memorial Hospital Physician Partners - Blountstown Clinic in Blountstown, and the Wakulla clinic based out of Crawfordville, in addition to many other locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Problem-Solving for Rural Heart Failure Dyads

Lucinda Graven 2020. "Problem-Solving for Rural Heart Failure Dyads". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04549181.