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Behavioral Intervention

Basic palliative care coaching + 4 monthly follow-up calls for Heart Failure (UPHOLDS Trial)

Q: What is the current number of individuals being admitted into this research investigation?

<p>Indeed, the information available on clinicaltrials.gov highlights that this investigation is actively seeking participants. Initially shared on February 15th, 2024, and most recently revised on February 1st of the same year, this trial aims to enroll a total of 64 patients at a single designated site.</p>

Q: Are there ongoing efforts to actively enroll participants in this trial?

<p>As per clinicaltrials.gov, this investigation is presently enrolling volunteers. The trial was initially published on February 15th, 2024 and most recently revised on February 1st of the same year.</p>

N/A

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Recent hospitalization with primary diagnosis of acute, decompensated heart failure (discharged < last 6 months)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 and 24 weeks after baseline

Awards & highlights

UPHOLDS Trial Summary

"This trial aims to test the effectiveness of an intervention called UPHOLDS for improving the quality of life of older adults with advanced heart failure. The trial will involve 64 participants who will receive different

Who is the study for?

This trial is for adults over 50 with advanced heart failure, recently hospitalized for it, and either part of a health disparity group or living in rural areas. They must speak English, be willing to participate fully, and have phone access.Check my eligibility

What is being tested?

The UPHOLDS intervention aims to improve life quality in older adults with advanced heart failure through palliative care coaching. It tests different combinations of psychoeducation sessions, financial coaching, specialty consultations, and follow-up calls.See study design

What are the potential side effects?

Since this study focuses on non-medical interventions like education and coaching rather than drugs or medical procedures, traditional side effects are not expected; however participants may experience emotional or psychological responses.

UPHOLDS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was hospitalized for worsening heart failure less than 6 months ago.

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I am 50 years old or older.

Select...

My heart failure is severe, limiting my daily activities significantly.

UPHOLDS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 and 24 weeks after baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 and 24 weeks after baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 24 weeks after baseline for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Acceptability of Intervention and Study Procedures

Feasibility of Intervention Delivery and Data Collection

Secondary outcome measures

Financial toxicity using the Comprehensive score for financial Toxicity

Mood using the Hospital Anxiety and Depression Scale

Quality of Life using the Kansas City Cardiomyopathy Questionnaire- 12

UPHOLDS Trial Design

16Treatment groups

Experimental Treatment

Group I: Basic palliative care coaching + outpatient visit + 4 monthly follow-up callsExperimental Treatment1 Intervention

4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, one-time Comprehensive Specialty Outpatient Palliative Care Clinic guided by the National Consensus Project for Quality Palliative Care Guidelines, and monthly follow-up calls for 4 months

Group II: Basic palliative care coaching + outpatient visit + 1 monthly follow-up callExperimental Treatment1 Intervention

Group III: Basic palliative care coaching + financial coaching + outpatient visit + 4 monthly follow-up callsExperimental Treatment1 Intervention

4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, 1 telehealth session on strategies to address healthcare-related financial toxicity, one-time Comprehensive Specialty Outpatient Palliative Care Clinic guided by the National Consensus Project for Quality Palliative Care Guidelines, and monthly follow-up calls for 4 months

Group IV: Basic palliative care coaching + financial coaching + outpatient visit + 1 monthly follow-up callExperimental Treatment1 Intervention

Group V: Basic palliative care coaching + financial coaching + 4 monthly follow-up callsExperimental Treatment1 Intervention

Group VI: Basic palliative care coaching + financial coaching + 1 monthly follow-up callExperimental Treatment1 Intervention

Group VII: Basic palliative care coaching + 4 monthly follow-up callsExperimental Treatment1 Intervention

4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, and monthly follow-up calls for 4 months

Group VIII: Basic palliative care coaching + 1 monthly follow-up callExperimental Treatment1 Intervention

4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, and a single monthly follow-up call

Group IX: Advanced palliative care coaching + outpatient visit + 4 monthly follow-up callsExperimental Treatment1 Intervention

8 telehealth sessions on principles of self-care, symptom management, and advanced care planning: This component level will expand the depth and topic range of content offered in the 4 sessions into eight 20-30 minute sessions, one-time Comprehensive Specialty Outpatient Palliative Care Clinic guided by the National Consensus Project for Quality Palliative Care Guidelines, and monthly follow-up calls for 4 months

Group X: Advanced palliative care coaching + outpatient visit + 1 monthly follow-up callExperimental Treatment1 Intervention

Group XI: Advanced palliative care coaching + financial coaching + outpatient visit + 4 monthly followup callsExperimental Treatment1 Intervention

8 telehealth sessions on principles of self-care, symptom management, and advanced care planning: This component level will expand the depth and topic range of content offered in the 4 sessions into eight 20-30 minute sessions,1 telehealth session on strategies to address healthcare-related financial toxicity, one-time Comprehensive Specialty Outpatient Palliative Care Clinic guided by the National Consensus Project for Quality Palliative Care Guidelines, and monthly follow-up calls for 4 months

Group XII: Advanced palliative care coaching + financial coaching + outpatient visit + 1 monthly follow-up callExperimental Treatment1 Intervention

8 telehealth sessions on principles of self-care, symptom management, and advanced care planning: This component level will expand the depth and topic range of content offered in the 4 sessions into eight 20-30 minute sessions, 1 telehealth session on strategies to address healthcare-related financial toxicity, one-time Comprehensive Specialty Outpatient Palliative Care Clinic guided by the National Consensus Project for Quality Palliative Care Guidelines, and a single monthly follow-up call

Group XIII: Advanced palliative care coaching + financial coaching + 4 monthly follow-up callsExperimental Treatment1 Intervention

8 telehealth sessions on principles of self-care, symptom management, and advanced care planning: This component level will expand the depth and topic range of content offered in the 4 sessions into eight 20-30 minute sessions, 1 telehealth session on strategies to address healthcare-related financial toxicity, and monthly follow-up calls for 4 months

Group XIV: Advanced palliative care coaching + financial coaching + 1 monthly follow-up callExperimental Treatment1 Intervention

Group XV: Advanced palliative care coaching + 4 monthly follow-up callsExperimental Treatment1 Intervention

Group XVI: Advanced palliative care coaching + 1 monthly follow-up callExperimental Treatment1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,598 Total Patients Enrolled

9 Trials studying Heart Failure

41,416 Patients Enrolled for Heart Failure

National Institute of Nursing Research (NINR)NIH

580 Previous Clinical Trials

10,376,497 Total Patients Enrolled

34 Trials studying Heart Failure

12,550 Patients Enrolled for Heart Failure

Frequently Asked Questions

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

What is the current number of individuals being admitted into this research investigation?

"Indeed, the information available on clinicaltrials.gov highlights that this investigation is actively seeking participants. Initially shared on February 15th, 2024, and most recently revised on February 1st of the same year, this trial aims to enroll a total of 64 patients at a single designated site."

Answered by AI

Are there ongoing efforts to actively enroll participants in this trial?

"As per clinicaltrials.gov, this investigation is presently enrolling volunteers. The trial was initially published on February 15th, 2024 and most recently revised on February 1st of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Optimization Pilot to Optimize An Early Palliative Care Intervention for Advanced Heart Failure

Rachel Wells 2024. "An Optimization Pilot to Optimize An Early Palliative Care Intervention for Advanced Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05879887.