HIVFACENCT01289444
Longitudinal Pediatric Palliative Care: Quality of Life & Spiritual Struggle
A study testing FAmily CEntered (FACE) ACP in people with HIV, run by Maureen Lyon at 5 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 14 to 21 years
- Conditions the study is for
- HIV
- What is being tested?
- FAmily CEntered (FACE) ACP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2011to Jul 2014
- Phase
- Interventional
- 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 14 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Children's Diagnostic & Treatment Center (Broward Health)
Fort Lauderdale, Florida, 33316
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Univeristy of Miami Miller School of Medicine
Miami, Florida, 33136
Howard University Hospital
Washington D.C., District of Columbia, 20060
Children's National Medical Center
Washington D.C., District of Columbia, 22314
About this study
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.
Read more
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.
Read the detailed description
Our goal is to advance palliative care with children and their families aimed at relieving suffering (psychological, spiritual, physical) and maximizing quality of life. Left unprepared for end-of-life decisions, miscommunication and disagreements may result in families being charged with neglect, court battles and even legislative intervention. We propose building on our R34, evidence based model, the Family Centered (FACE) Advance Care Planning intervention, to test our full theoretical model examining the putative mediators and moderators, and spiritual struggle (negative religious coping) with a sicker group and adolescents with AIDS in an adequately powered randomized, clinical, 2-arm, controlled trial. FACE is a culturally sensitive and developmentally appropriate, manualized family intervention based on transactional stress and coping theory, which prepares adolescents with HIV/AIDS and their families for end-of-life decision-making through problem solving. Theoretically, threat appraisal is related to Lazarus' concept of primary appraisal, particularly the way in which an event threatens the child's goals or values. Spiritual struggle (negative religious coping) may be a source of distress, causing disparities in palliative care and outcomes. We will test the efficacy of the FACE intervention for increasing communication and congruence in end-of-life treatment preferences between teens with AIDS and their surrogates, and determine if increased congruence can be maintained over time. We will also examine the impact of the FACE intervention on decisional conflict, quality of communication, and patient quality of life. We will also evaluate hypothesized mediators (threat appraisal, HAART adherence) and moderator (spiritual struggle) of study outcomes, including hospitalizations. We will recruit from hospital-based clinics and randomize 130 adolescent/surrogate dyads (N=260 subjects) to either Control (N=65 dyads) or FACE Intervention (N=65 dyads). Participants with HIV dementia, severe depression, suicidality or homicidality or in foster care will not be allowed to participate. Three 60- to 90-minute sessions will be conducted with a certified interviewer at weekly intervals: FACE: 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 will also be administered in a family group format to control for time, attention, and Hawthorn effects: Session 1: Developmental History, Session 2: Safety Tips, and Session 3: Safety Tips. Standardized self-report measures will be administered at baseline, immediate post intervention (3 month), and 6, 12 and 18 month post intervention. Generalized estimating equation (GEE) will assess outcomes.
- Conditions
- HIV
- Being tested
- FAmily CEntered (FACE) ACP, Healthy Living Control
- Keywords
- palliative care, AIDS, adolescents, quality of life, adherence, spiritual, threat appraisal, treatment congruence, treatment preferences, dialysis, hospitalization, communication, family intervention, Family Centered Advance Care Planning, decision making, advance care planning, end of life
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Communication, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAmily CEntered (FACE) ACPBehavioural
Also called FACE
Three-60 to 90 minute sessions scheduled one week apart: 1) To assess values, spiritual and other beliefs, and life experiences with illness and EOL care \& when to initiate advance care planning. 2) To facilitate conversations and shared decision-making between the adolescent and guardian/surrogate about palliative care \& prepare the surrogate to be able to fully represent the adolescent's wishes. 3) Which person the teen wants to make health care decisions for him/her; The kind of medical treatment the teen wants; How comfortable the teen wants to be; How the teen wants people to treat him/her; What teen wants loved ones to know; Any spiritual or religious concerns teens may have.
Healthy Living ControlBehavioural
Also called HLC
Active Comparator: Three 60 to 90 minute sessions scheduled one week apart. 1. Developmental History. Goal: To take a non-medical developmental history. The RA-Control will conduct the session in a structured interview format. Administered with all medical questions removed to prevent any risk of contamination with the experimental condition. 2. Safety Tips. Goal: To provide safety information using the American Academy of Pediatrics Bright Futures counseling guides. Participants will be asked questions about seat belt use, etc. Safety information will be provided.
- Nutrition Tips. Goal: To provide safety information using the American Academy of Pediatrics Bright Futures nutrition/counseling guides.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Living Control | Active comparator | Session 1. Developmental History. Goal: To take a non-medical developmental history. The RA-Control will conduct the session in a structured interview format. Administered, with all medical questions removed to prevent any risk of contamination with the experimental condition.
Session 2. Safety Tips. Goal: To provide safety information using the American Academy of Pediatrics Bright Futures counseling guides. Participants will be asked questions about seat belt use, etc. Safety information will be provided.
Session 3. Nutrition Tips. Goal: To provide safety information using the American Academy of Pediatrics Bright Futures nutrition/counseling guides. The Administered by the trained RA-Control to prevent contamination with the FACE condition. Receives: Behavioral: Healthy Living Control |
| FAmily CEntered (FACE) ACP | Experimental | Three-60 to 90 minute sessions scheduled one week apart: 1) To assess values, spiritual and other beliefs, and life experiences with illness and EOL care \& when to initiate advance care planning. 2) To facilitate conversations and shared decision-making between the adolescent and guardian/surrogate about palliative care \& prepare the surrogate to be able to fully represent the adolescent's wishes. 3) Which person the teen wants to make health care decisions for him/her; The kind of medical treatment the teen wants; How comfortable the teen wants to be; How the teen wants people to treat him/her; What teen wants loved ones to know; Any spiritual or religious concerns teens may have. Receives: Behavioral: FAmily CEntered (FACE) ACP |
What is being measured
The primary outcome is the main question the study is designed to answer.
congruence in treatment preferences
Measured by the Statement of Treatment Preferences
Measured: Change from baseline in Congruence in Treatment Preferences at 18 months post-intervention compared to control
Secondary outcomes (3)
QOL
Measured by score on Varni's Peds QoL
Measured: Change from baseline in Quality of Life at 18 months post-intervention compared to control
Utilization of hospitalization
Hospitalization will be measured by chart review. Each site has hospital based services for patient population
Measured: Change from baseline in hospitalizations at 18 month follow-up post intervention compared to control
Utilization of dialysis
Use of dialysis will be measured by chart review.
Measured: Change from baseline in use of dialysis at 18 month post-intervention compared to control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maureen Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- St. Jude Children's Research Hospital, Johns Hopkins University, University of Miami, Howard University, Broward Health
- Responsible party
- Sponsor-investigator, Maureen Lyon, Children's National Research Institute
- Investigators
- Maureen E Lyon, PhD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289444
- Sponsor's protocol ID
- 1R01NR012711-01
- Acronym
- FACE
- Status last verified
- Oct 2021
- First submitted
- 28 Jan 2011
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified participant data will be shared upon request to the PI after the close of the study.
Publications
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.
PubMed 19327074Lyon 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.
PubMed 19171571Lyon 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. doi: 10.2147/hiv.s7507. Epub 2010 Feb 18.
PubMed 22096382Lyon 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.
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.
PubMed 23930080Rosenberg 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.
PubMed 27749945Lee 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
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.
PubMed 22664645Dallas 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):e20161854. doi: 10.1542/peds.2016-1854. Epub 2016 Nov 1.
PubMed 27940700Lyon 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.
PubMed 27071797Lyon 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: 10.1080/09540121.2017.1308463. Epub 2017 Mar 30.
PubMed 28359212Lyon 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 families. BMJ Support Palliat Care. 2019 Mar;9(1):e22. doi: 10.1136/bmjspcare-2016-001224. Epub 2017 Sep 21.
PubMed 28935629Lyon 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):e20173869. doi: 10.1542/peds.2017-3869. Epub 2018 Oct 19.
PubMed 30341154Lyon ME, D'Angelo LJ, Cheng YI, Dallas RH, Garvie PA, Wang J; Adolescent Palliative Care Consortium. The influence of religious beliefs and practices on health care decision-making among HIV positive adolescents. AIDS Care. 2020 Jul;32(7):896-900. doi: 10.1080/09540121.2019.1668523. Epub 2019 Sep 19.
PubMed 31535560
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Pediatric Palliative Care: Quality of Life & Spiritual Struggle
- ClinicalTrials.gov ID
- NCT01289444
- Acronym / sponsor ID
- FACE / 1R01NR012711-01
- Conditions
- HIV
- Keywords
- palliative care, AIDS, adolescents, quality of life, adherence, spiritual, threat appraisal, treatment congruence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Maureen LyonUniversity, hospital or other
- Collaborators
- St. Jude Children's Research Hospital, Johns Hopkins University, University of Miami, Howard University, Broward Health
- Study start
- Jul 2011 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 3 Feb 2011 (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.
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.
Detailed description
Our goal is to advance palliative care with children and their families aimed at relieving suffering (psychological, spiritual, physical) and maximizing quality of life. Left unprepared for end-of-life decisions, miscommunication and disagreements may result in families being charged with neglect, court battles and even legislative intervention. We propose building on our R34, evidence based model, the Family Centered (FACE) Advance Care Planning intervention, to test our full theoretical model examining the putative mediators and moderators, and spiritual struggle (negative religious coping) with a sicker group and adolescents with AIDS in an adequately powered randomized, clinical, 2-arm, controlled trial. FACE is a culturally sensitive and developmentally appropriate, manualized family intervention based on transactional stress and coping theory, which prepares adolescents with HIV/AIDS and their families for end-of-life decision-making through problem solving. Theoretically, threat appraisal is related to Lazarus' concept of primary appraisal, particularly the way in which an event threatens the child's goals or values. Spiritual struggle (negative religious coping) may be a source of distress, causing disparities in palliative care and outcomes. We will test the efficacy of the FACE intervention for increasing communication and congruence in end-of-life treatment preferences between teens with AIDS and their surrogates, and determine if increased congruence can be maintained over time. We will also examine the impact of the FACE intervention on decisional conflict, quality of communication, and patient quality of life. We will also evaluate hypothesized mediators (threat appraisal, HAART adherence) and moderator (spiritual struggle) of study outcomes, including hospitalizations. We will recruit from hospital-based clinics and randomize 130 adolescent/surrogate dyads (N=260 subjects) to either Control (N=65 dyads) or FACE Intervention (N=65 dyads). Participants with HIV dementia, severe depression, suicidality or homicidality or in foster care will not be allowed to participate. Three 60- to 90-minute sessions will be conducted with a certified interviewer at weekly intervals: FACE: 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 will also be administered in a family group format to control for time, attention, and Hawthorn effects: Session 1: Developmental History, Session 2: Safety Tips, and Session 3: Safety Tips. Standardized self-report measures will be administered at baseline, immediate post intervention (3 month), and 6, 12 and 18 month post intervention. Generalized estimating equation (GEE) will assess outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Living Control | Active comparator | Behavioral: Healthy Living ControlSession 1. Developmental History. Goal: To take a non-medical developmental history. The RA-Control will conduct the session in a structured interview format. Administered, with all medical questions removed to prevent any risk of contamination with the experimental condition. Session 2. Safety Tips. Goal: To provide safety information using the American Academy of Pediatrics Bright Futures counseling guides. Participants will be asked questions about seat belt use, etc. Safety information will be provided. Session 3. Nutrition Tips. Goal: To provide safety information using the American Academy of Pediatrics Bright Futures nutrition/counseling guides. The Administered by the trained RA-Control to prevent contamination with the FACE condition. |
| FAmily CEntered (FACE) ACP | Experimental | Behavioral: FAmily CEntered (FACE) ACPThree-60 to 90 minute sessions scheduled one week apart: 1) To assess values, spiritual and other beliefs, and life experiences with illness and EOL care \& when to initiate advance care planning. 2) To facilitate conversations and shared decision-making between the adolescent and guardian/surrogate about palliative care \& prepare the surrogate to be able to fully represent the adolescent's wishes. 3) Which person the teen wants to make health care decisions for him/her; The kind of medical treatment the teen wants; How comfortable the teen wants to be; How the teen wants people to treat him/her; What teen wants loved ones to know; Any spiritual or religious concerns teens may have. |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAmily CEntered (FACE) ACPAlso: FACEThree-60 to 90 minute sessions scheduled one week apart: 1) To assess values, spiritual and other beliefs, and life experiences with illness and EOL care \& when to initiate advance care planning. 2) To facilitate conversations and shared decision-making between the adolescent and guardian/surrogate about palliative care \& prepare the surrogate to be able to fully represent the adolescent's wishes. 3) Which person the teen wants to make health care decisions for him/her; The kind of medical treatment the teen wants; How comfortable the teen wants to be; How the teen wants people to treat him/her; What teen wants loved ones to know; Any spiritual or religious concerns teens may have. | Behavioural | FAmily CEntered (FACE) ACP |
| Healthy Living ControlAlso: HLCActive Comparator: Three 60 to 90 minute sessions scheduled one week apart. 1. Developmental History. Goal: To take a non-medical developmental history. The RA-Control will conduct the session in a structured interview format. Administered with all medical questions removed to prevent any risk of contamination with the experimental condition. 2. Safety Tips. Goal: To provide safety information using the American Academy of Pediatrics Bright Futures counseling guides. Participants will be asked questions about seat belt use, etc. Safety information will be provided. 3. Nutrition Tips. Goal: To provide safety information using the American Academy of Pediatrics Bright Futures nutrition/counseling guides. | Behavioural | Healthy Living Control |
Primary outcome
congruence in treatment preferences
Time frame: Change from baseline in Congruence in Treatment Preferences at 18 months post-intervention compared to control
Measured by the Statement of Treatment Preferences
3 secondary outcomes
QOL
Time frame: Change from baseline in Quality of Life at 18 months post-intervention compared to control
Utilization of hospitalization
Time frame: Change from baseline in hospitalizations at 18 month follow-up post intervention compared to control
Utilization of dialysis
Time frame: Change from baseline in use of dialysis at 18 month post-intervention compared to control
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 12 Oct 2021.
- Background: PubMed 19327074Lyon 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.
- Background: PubMed 19171571Lyon 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.
- Background: PubMed 22096382Lyon 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. doi: 10.2147/hiv.s7507. Epub 2010 Feb 18.
- BackgroundLyon 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.
- Background: PubMed 23930080Wilkins 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.
- Background: PubMed 27749945Rosenberg 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.
- BackgroundLee 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
- Results publication: PubMed 22664645Dallas 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.
- Results publication: PubMed 27940700Dallas 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):e20161854. doi: 10.1542/peds.2016-1854. Epub 2016 Nov 1.
- Results publication: PubMed 27071797Lyon 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.
- Results publication: PubMed 28359212Lyon 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: 10.1080/09540121.2017.1308463. Epub 2017 Mar 30.
- Results publication: PubMed 28935629Lyon 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 families. BMJ Support Palliat Care. 2019 Mar;9(1):e22. doi: 10.1136/bmjspcare-2016-001224. Epub 2017 Sep 21.
- Individual participant dataSharing planned: Yes. De-identified participant data will be shared upon request to the PI after the close of the study.
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HIV, Substance Use Disorder
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.
Maureen E Lyon, PhD principal investigator
Children's National Research Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAmily CEntered (FACE) ACP in people with HIV, run by Maureen Lyon at 5 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 0 inclusion and 7 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 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does the primary outcome measure?
congruence in treatment preferences (time frame: Change from baseline in Congruence in Treatment Preferences at 18 months post-intervention compared to control). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01289444, which also lists 14 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 12 Oct 2021.