HIV Clinical Trial
— FACEOfficial title:
Longitudinal Pediatric Palliative Care: Quality of Life & Spiritual Struggle
NCT number | NCT01289444 |
Other study ID # | 1R01NR012711-01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2011 |
Est. completion date | July 2014 |
Verified date | October 2021 |
Source | Children's National Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Our goal is to advance palliative care to adolescents and their families. We hope our study will decrease suffering (psychological, spiritual, physical) and increase quality of life (QOL). Left unprepared for end-of-life decisions, miscommunication and disagreements may result in families being charged with neglect or court battles over treatment choices. FAmily CEntered (FACE) Advance Care Planning helps prepare adolescents with HIV/AIDS and their families for future medical decisions. We hope to increase families' understanding of their teens' wishes for end-of-life care and to decrease conflict. We will also study communication and spiritual struggle Families will be randomized into the either the Control (N=65 families) or FACE Intervention (N=65 families). FACE families will meet with a trained/certified researcher for three 60- to 90-minute sessions scheduled one week apart: Session 1: Lyon Advance Care Planning Survey© - Adolescent and Surrogate Versions: Session 2: The Respecting Choices Interview® Session 3: Completion of The Five Wishes©. Control families will also meet with a researcher for three 60-to 90-minute sessions scheduled one week apart: Session 1: Developmental History, Session 2: Safety Tips, and Session 3: Nutrition. Questionnaires will be administered five times, when first seen, at 3, 6, 12 and 18 months from the time of Session 3. Hypothesis 1: Compared to an active control, FACE will relieve psychological suffering by 1) increasing congruence in treatment preferences between teens with AIDS and their surrogates, 2) decreasing decisional conflict regarding EOL decision making for future medical treatment in adolescents with AIDS; 3) increasing quality communication about EOL care in adolescent/legal guardian or surrogate dyads; 4) and maximizing QOL. Hypothesis 2: In addition to the direct effects, FACE will also indirectly affect QOL through dimensions of threat appraisal. Hypothesis 3: FACE will have stronger effects on the QOL measures among patients who have less spiritual struggle. Hypothesis 4: Spiritual struggle has both direct and indirect effects on hospitalization/dialysis use. FACE will also affect hospitalization/dialysis use indirectly through threat appraisal and HAART adherence.
Status | Completed |
Enrollment | 216 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 21 Years |
Eligibility | Adolescent Inclusion Criteria: - Diagnosed ever with HIV; - All ethnic groups; - Knows HIV status; - Speaks English; - Absence of active homicidality or suicidality; - Absence of HIV dementia; - IQ >69; - Consent from the legal guardian for adolescents aged 14-17; - Consent from the surrogate for adolescents aged 18-21; - Assent from adolescent aged 14-17; - Consent from adolescent aged 18-21; - Absence of severe depression; - Not in foster care Legal Guardian Inclusion Criteria for Legal Guardians of Adolescents Age 14-17: - Adolescent willingness to discuss problems related to HIV/AIDS with them; - Age 18 or older; - Ability to speak English; - Absence of active homicidality, suicidality, or psychosis; - Absence of HIV dementia; - Legal guardian; - Consent to participate; Consent for his/her adolescent to participate; - Knows HIV status of adolescent; - Absence of depression in the severe range; Surrogate Inclusion Criteria for Adolescents Age 18-21: - Selected by adolescent aged 18 to 21; - Age 18 or older; - Willingness to discuss problems related to HIV and end-of-life; - Absence of active homicidality, suicidality, or psychosis; - Absence of HIV dementia; - Speaks English; - Consent to participate; - Knows HIV status of adolescent. - Absence of severe depression; Exclusion Criteria: - adolescent or surrogate does not know HIV diagnosis - being in foster care - developmentally delayed - scoring below the cut off on the HIV Dementia Scale - scoring above the cut off for depressive symptoms on the Beck Depression Inventory - homicidal, suicidal or psychotic on screening - does not speak English |
Country | Name | City | State |
---|---|---|---|
United States | Children's Diagnostic & Treatment Center (Broward Health) | Fort Lauderdale | Florida |
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
United States | Univeristy of Miami Miller School of Medicine | Miami | Florida |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | Howard University Hospital | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Maureen Lyon | Broward Health, Howard University, Johns Hopkins University, St. Jude Children's Research Hospital, University of Miami |
United States,
Dallas RH, Kimmel A, Wilkins ML, Rana S, Garcia A, Cheng YI, Wang J, Lyon ME; Adolescent Palliative Care Consortium. Acceptability of Family-Centered Advanced Care Planning for Adolescents With HIV. Pediatrics. 2016 Dec;138(6). pii: e20161854. Epub 2016 N — View Citation
Dallas RH, Wilkins ML, Wang J, Garcia A, Lyon ME. Longitudinal Pediatric Palliative Care: Quality of Life & Spiritual Struggle (FACE): design and methods. Contemp Clin Trials. 2012 Sep;33(5):1033-43. doi: 10.1016/j.cct.2012.05.009. Epub 2012 Jun 1. — View Citation
Lee BC, et al. Who Will Speak for Me? Disparities in Palliative Care Research with Unbefriended Adolescents Living with HIV/AIDS. Journal of Palliative Medicine. 20(10), 2017. doi: 10.1089/jpm.207.0053
Lyon ME, D'Angelo LJ, Cheng YI, Dallas RH, Garvie PA, Wang J. The influence of religiousness beliefs and practices on health care decision-making among HIV positive adolescents. AIDS Care. 2019 Sep 19:1-5. http://dx.doi.org/10.1080/09540121.2019.1668523.
Lyon ME, D'Angelo LJ, Dallas RH, Hinds PS, Garvie PA, Wilkins ML, Garcia A, Briggs L, Flynn PM, Rana SR, Cheng YI, Wang J. A randomized clinical trial of adolescents with HIV/AIDS: pediatric advance care planning. AIDS Care. 2017 Oct;29(10):1287-1296. doi — View Citation
Lyon ME, Dallas RH, Garvie PA, Wilkins ML, Garcia A, Cheng YI, Wang J; Adolescent Palliative Care Consortium. Paediatric advance care planning survey: a cross-sectional examination of congruence and discordance between adolescents with HIV/AIDS and their — View Citation
Lyon ME, Garvie PA, Briggs L, He J, D'Angelo LJ, McCarter R. (September, 2010 on line, in press). Does spirituality protect psychological adjustment, quality of life or medication adherence when talking to HIV+ Adolescents about death and dying? Journal of Adolescent Health.
Lyon ME, Garvie PA, Briggs L, He J, Malow R, D'Angelo LJ, McCarter R. Is it safe? Talking to teens with HIV/AIDS about death and dying: a 3-month evaluation of Family Centered Advance Care (FACE) planning - anxiety, depression, quality of life. HIV AIDS (Auckl). 2010;2:27-37. Epub 2010 Feb 18. — View Citation
Lyon ME, Garvie PA, Briggs L, He J, McCarter R, D'Angelo LJ. Development, feasibility, and acceptability of the Family/Adolescent-Centered (FACE) Advance Care Planning intervention for adolescents with HIV. J Palliat Med. 2009 Apr;12(4):363-72. doi: 10.1089/jpm.2008.0261. — View Citation
Lyon ME, Garvie PA, D'Angelo LJ, Dallas RH, Briggs L, Flynn PM, Garcia A, Cheng YI, Wang J; Adolescent Palliative Care Consortium. Advance Care Planning and HIV Symptoms in Adolescence. Pediatrics. 2018 Nov;142(5). pii: e20173869. doi: 10.1542/peds.2017-3 — View Citation
Lyon ME, Garvie PA, McCarter R, Briggs L, He J, D'Angelo LJ. Who will speak for me? Improving end-of-life decision-making for adolescents with HIV and their families. Pediatrics. 2009 Feb;123(2):e199-206. doi: 10.1542/peds.2008-2379. — View Citation
Lyon ME, Kimmel AL, Cheng YI, Wang J. The Role of Religiousness/Spirituality in Health-Related Quality of Life Among Adolescents with HIV: A Latent Profile Analysis. J Relig Health. 2016 Oct;55(5):1688-99. doi: 10.1007/s10943-016-0238-3. — View Citation
Rosenberg AR, Wolfe J, Wiener L, Lyon M, Feudtner C. Ethics, Emotions, and the Skills of Talking About Progressing Disease With Terminally Ill Adolescents: A Review. JAMA Pediatr. 2016 Dec 1;170(12):1216-1223. doi: 10.1001/jamapediatrics.2016.2142. Review. — View Citation
Wilkins ML, Dallas RH, Fanone KE, Lyon ME. Pediatric palliative care for youth with HIV/AIDS: systematic review of the literature. HIV AIDS (Auckl). 2013 Jul 29;5:165-79. doi: 10.2147/HIV.S44275. Print 2013. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | congruence in treatment preferences | Measured by the Statement of Treatment Preferences | Change from baseline in Congruence in Treatment Preferences at 18 months post-intervention compared to control | |
Secondary | QOL | Measured by score on Varni's Peds QoL | Change from baseline in Quality of Life at 18 months post-intervention compared to control | |
Secondary | Utilization of hospitalization | Hospitalization will be measured by chart review. Each site has hospital based services for patient population | Change from baseline in hospitalizations at 18 month follow-up post intervention compared to control | |
Secondary | Utilization of dialysis | Use of dialysis will be measured by chart review. | Change from baseline in use of dialysis at 18 month post-intervention compared to control |
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