Health Values and Spirituality in Veterans With HIV/AIDS | NCT00057109

Studies
Health Values and Spirituality in Veterans With HIV/AIDS

NCT00057109

Sponsor

US Department of Veterans Affairs

Status

Completed

Last Update Posted

Apr 7, 2015Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Quality of Life
HIV
Spirituality

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Jun 2005Actual

First Submitted Date

Mar 27, 2003

First Submission Date that Met QC Criteria

Mar 27, 2003

First Posted Date

Mar 28, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2015

Last Update Posted Date

Apr 7, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We have previously shown that: 1) time tradeoff utilities for current health are high, indicating that patients have a strong will to live; 2) half of patients felt that their life was better now than before they were HIV-infected; and 3) certain non-health-related factors such as spirituality and concern and love for one�s children correlated with health values and a sense that life has improved.

Detailed Description

Background:

Objectives:

1) To assess health values of veterans and non-veterans with HIV/AIDS; 2) To characterize spirituality in patients with HIV/AIDS; 3) To derive a power function relating health ratings to utilities; and 4) To assess whether society assigns higher values to health states for veterans than for non-veterans.

Methods:

We interviewed 100 representative veterans with HIV/AIDS from the Cincinnati and Pittsburgh VAMCs and, concurrently, 350 non-veterans with HIV/AIDS from Cincinnati and Washington, DC, twice over 12-18 months. The patient questionnaire included clinical and demographic data; health values measures; a question comparing life now with life before being infected with HIV; and measures of health status/health concerns, HIV symptoms, depressive symptoms, spirituality/religion, adherence, social support, self-esteem, and optimism. We also assessed how medical house officers rate and value the health state of a hypothetical patient with congestive heart failure, identified either as a 72-year-old veteran or merely as a 72-year-old male.

Status:

Data collection completed ahead of schedule. Several manuscripts published with others to be submitted soon.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
Group 1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults with HIV/AIDS

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joel Tsevat, MD MPH	Cincinnati VA Medical Center, Cincinnati, OH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cincinnati VA Medical Center, Cincinnati, OH		Cincinnati	Ohio	45220	United States
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17083502	Result	Sherman SN, Mrus JM, Yi MS, Feinberg J, Tsevat J. How do patients with HIV/AIDS understand and respond to health value questions? J Gen Intern Med. 2006 Dec;21 Suppl 5(Suppl 5):S56-61. doi: 10.1111/j.1525-1497.2006.00647.x.
17083501	Result	Cotton S, Puchalski CM, Sherman SN, Mrus JM, Peterman AH, Feinberg J, Pargament KI, Justice AC, Leonard AC, Tsevat J. Spirituality and religion in patients with HIV/AIDS. J Gen Intern Med. 2006 Dec;21 Suppl 5(Suppl 5):S5-13. doi: 10.1111/j.1525-1497.2006.00642.x.