Quality of LifeNCT00057109
Health Values and Spirituality in Veterans With HIV/AIDS
An observational study of Quality of Life and HIV, run by US Department of Veterans Affairs at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, HIV, Spirituality
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento Jun 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with HIV/AIDS
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, 45220
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
About this study
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.
Read the detailed description
Background:
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.
Objectives:
- 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.
- Conditions
- Quality of Life, HIV, Spirituality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2003 (estimated)
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joel Tsevat, MD MPH, Principal investigator, Cincinnati VA Medical Center, Cincinnati, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057109
- Sponsor's protocol ID
- ECI 01-195
- Status last verified
- Dec 2005
- First submitted
- 27 Mar 2003
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17083502Cotton 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.
PubMed 17083501Kudel I, Farber SL, Mrus JM, Leonard AC, Sherman SN, Tsevat J. Patterns of responses on health-related quality of life questionnaires among patients with HIV/AIDS. J Gen Intern Med. 2006 Dec;21 Suppl 5(Suppl 5):S48-55. doi: 10.1111/j.1525-1497.2006.00645.x.
PubMed 17083500Cotton S, Tsevat J, Szaflarski M, Kudel I, Sherman SN, Feinberg J, Leonard AC, Holmes WC. Changes in religiousness and spirituality attributed to HIV/AIDS: are there sex and race differences? J Gen Intern Med. 2006 Dec;21 Suppl 5(Suppl 5):S14-20. doi: 10.1111/j.1525-1497.2006.00641.x.
PubMed 17083495Mrus JM, Leonard AC, Yi MS, Sherman SN, Fultz SL, Justice AC, Tsevat J. Health-related quality of life in veterans and nonveterans with HIV/AIDS. J Gen Intern Med. 2006 Dec;21 Suppl 5(Suppl 5):S39-47. doi: 10.1111/j.1525-1497.2006.00644.x.
PubMed 17083499Tsevat J, Leonard AC, Szaflarski M, Sherman SN, Cotton S, Mrus JM, Feinberg J. Change in quality of life after being diagnosed with HIV: a multicenter longitudinal study. AIDS Patient Care STDS. 2009 Nov;23(11):931-7. doi: 10.1089/apc.2009.0026.
PubMed 19821724Szaflarski M, Ritchey PN, Leonard AC, Mrus JM, Peterman AH, Ellison CG, McCullough ME, Tsevat J. Modeling the effects of spirituality/religion on patients' perceptions of living with HIV/AIDS. J Gen Intern Med. 2006 Dec;21 Suppl 5(Suppl 5):S28-38. doi: 10.1111/j.1525-1497.2006.00646.x.
PubMed 17083497Yi MS, Mrus JM, Wade TJ, Ho ML, Hornung RW, Cotton S, Peterman AH, Puchalski CM, Tsevat J. Religion, spirituality, and depressive symptoms in patients with HIV/AIDS. J Gen Intern Med. 2006 Dec;21 Suppl 5(Suppl 5):S21-7. doi: 10.1111/j.1525-1497.2006.00643.x.
PubMed 17083496
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Values and Spirituality in Veterans With HIV/AIDS
- ClinicalTrials.gov ID
- NCT00057109
- Acronym / sponsor ID
- ECI 01-195
- Conditions
- Quality of Life, HIV, Spirituality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Jun 2005 (actual)
- First posted
- 28 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
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.
Objectives:
- 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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with HIV/AIDS
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publication: PubMed 17083502Sherman 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.
- Results publication: PubMed 17083501Cotton 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.
- Results publication: PubMed 17083500Kudel I, Farber SL, Mrus JM, Leonard AC, Sherman SN, Tsevat J. Patterns of responses on health-related quality of life questionnaires among patients with HIV/AIDS. J Gen Intern Med. 2006 Dec;21 Suppl 5(Suppl 5):S48-55. doi: 10.1111/j.1525-1497.2006.00645.x.
- Results publication: PubMed 17083495Cotton S, Tsevat J, Szaflarski M, Kudel I, Sherman SN, Feinberg J, Leonard AC, Holmes WC. Changes in religiousness and spirituality attributed to HIV/AIDS: are there sex and race differences? J Gen Intern Med. 2006 Dec;21 Suppl 5(Suppl 5):S14-20. doi: 10.1111/j.1525-1497.2006.00641.x.
- Results publication: PubMed 17083499Mrus JM, Leonard AC, Yi MS, Sherman SN, Fultz SL, Justice AC, Tsevat J. Health-related quality of life in veterans and nonveterans with HIV/AIDS. J Gen Intern Med. 2006 Dec;21 Suppl 5(Suppl 5):S39-47. doi: 10.1111/j.1525-1497.2006.00644.x.
- Results publication: PubMed 19821724Tsevat J, Leonard AC, Szaflarski M, Sherman SN, Cotton S, Mrus JM, Feinberg J. Change in quality of life after being diagnosed with HIV: a multicenter longitudinal study. AIDS Patient Care STDS. 2009 Nov;23(11):931-7. doi: 10.1089/apc.2009.0026.
- Results publication: PubMed 17083497Szaflarski M, Ritchey PN, Leonard AC, Mrus JM, Peterman AH, Ellison CG, McCullough ME, Tsevat J. Modeling the effects of spirituality/religion on patients' perceptions of living with HIV/AIDS. J Gen Intern Med. 2006 Dec;21 Suppl 5(Suppl 5):S28-38. doi: 10.1111/j.1525-1497.2006.00646.x.
- Results publication: PubMed 17083496Yi MS, Mrus JM, Wade TJ, Ho ML, Hornung RW, Cotton S, Peterman AH, Puchalski CM, Tsevat J. Religion, spirituality, and depressive symptoms in patients with HIV/AIDS. J Gen Intern Med. 2006 Dec;21 Suppl 5(Suppl 5):S21-7. doi: 10.1111/j.1525-1497.2006.00643.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Tsevat, MD MPH principal investigator
Cincinnati VA Medical Center, Cincinnati, OH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and HIV, run by US Department of Veterans Affairs at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00057109, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.