How the Elderly Live With Pain in Heart Failure

NCT01794728 | Completed

• 1 other identifier: 12D.115
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The How the Elderly Live with Pain in Heart Failure (HELP-HF) study provides the opportunity to assess the complaints of pain in a cohort of HF patient admitted to Thomas Jefferson University Hospital (TJUH). Additional information on their existing co-morbid conditions, an inventory of their prescribed medications, and details regarding the type of treatment interventions (over the counter analgesia and other comfort practices) they report using will be collected.

Conditions

Heart Failure

Keywords

Pain Management

Outcome Measures

Primary Outcomes (1)

• Change in characteristics and frequency of pain in a cohort of HF patients

  Assessment will be completed at baseline time of enrollment during hospitalization and again at 30 days after discharge. The instrument used is the Brief Pain Inventory questionnaire.

  Time of enrollment date and after 30 days.

Secondary Outcomes (2)

• Change in the analgesia and comfort measures selected to treat pain by a cohort of HF patients

  Time of enrollment date and after 30 days.

• Change in the relationship between pain and self- reported QOL in a cohort of HF patients

  Time of enrollment date and after 30 days.

Study Arms (1)

Elderly inpatients with heart failure

A single cohort group of elderly patients hospitalized for heart failure.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women age 60 or greater hospitalized with acute decompensated heart failure.

You may qualify if:

• Men and women ≥ 60 years.
• Admission to hospital for worsening HF

You may not qualify if:

• History of uncontrolled hypertension.
• Severe valve disease.
• End-stage (Stage D) HF, including treatment with chronic ionotropic drugs or left ventricular assist device support.
• Advanced malignancy or other medical condition with life expectancy less than 2 years or undergoing active chemotherapy or radiation therapy.
• Advanced chronic kidney disease (CKD) defined as estimated glomerular filtration rate (GFR) \< 20 mL/min/1.73 m2 based upon the Modification of Diet in Renal Disease (MDRD) study equation), or on chronic or intermittent dialysis or dialysis anticipated within the next 6 months.
• Chronic anemia with hemoglobin \< 9 gm/dl for males, \< 8 gm/dl for females or acute anemia requiring transfusion of 2 or more units of blood.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Heart Failure; Agnosia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David J Whellan, MD MHS

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2012
• First Posted: February 20, 2013
• Study Start: July 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 3, 2015

Record last verified: 2015-11

Locations

US (1)