Hepatitis CNCT00598416
Psychoeducation for Hepatitis and Alcohol Behaviors
A study testing Family-Responsive Psychoeducation Program (PERF) in people with Hepatitis C and Substance Abuse, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
The proposed project will apply a unique, effective family-responsive psychoeducation program, PsychoEducation Responsive to Families (PERF), for Hepatitis C Virus (HCV) treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Substance Abuse
- What is being tested?
- Family-Responsive Psychoeducation Program (PERF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Aug 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who are seropositive for HCV as determined by ELISA test and confirmed by direct measure of viral load as part of their clinical care
- Lack progressive or decompensated liver functions (manifest in jaundice, ascites, variceal bleeding, hepatic encephalopathy)
- Age at least 18 years
- Identified family member(s)/significant other(s) also willing to participate in the psychoeducation groups, and
- Ability to provide informed consent for research participation. "Family" will be defined to include biological relatives, as well as any non-biological individual or significant other considered "family" by either the ill member or his/her immediate family.
Who cannot join
- Inability to provide informed consent such as irreversible cognitive impairment precluding participation
- Progressive or decompensated liver functions (manifest in jaundice, ascites, variceal bleeding, hepatic encephalopathy), and
- Age <18 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Psychoeducation for HCV and Alcohol Behaviors
The proposed project will apply a unique, effective family-responsive psychoeducation program, PsychoEducation Responsive to Families (PERF), for Hepatitis C Virus (HCV) treatment. The goal is to demonstrate that the intervention will enlarge the eligibility of some patients for HCV treatment and help sustain others through it.
Read the detailed description
This study aims to evaluate the utility of a psychosocial intervention (PsychoEducation Responsive to Families; PERF), applied to help patients prepare for and sustain HCV treatment in the treatment setting. Through careful psychiatric diagnosis and multiple longitudinal assessments, this study will also shed further light on the course of comorbid alcohol use, drug use, and other psychiatric syndromes and their interrelationships. The proposed study combines an innovative psychoeducation program with traditional HCV patient care and education. The goal of this work is to improve treatment adherence, allowing individual drug regimens to achieve their optimal effectiveness and reach a wider patient population. Support and sustenance of patients from a psychosocial perspective while they are in treatment should also help deliver more patients to sustained suppression of HCV as well as help presently untreated patients and populations become candidates for this therapy-ultimately reducing the disease burden of increasing numbers of patients needing liver transplantation or facing imminent death.
- Conditions
- Hepatitis C, Substance Abuse
- Being tested
- Family-Responsive Psychoeducation Program (PERF)
- Keywords
- Hepatitis C, Substance Abuse, Psychoeducation, Psychiatric functioning, Physical Functioning, Quality of Life, NIAAA, Alcohol
- Medical subject headings
- Hepatitis C, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-Responsive Psychoeducation Program (PERF)Behavioural
Group psychoeducation for HCV patients and their primary caregiver.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation | Experimental | Not described Receives: Behavioral: Family-Responsive Psychoeducation Program (PERF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased treatment readiness and better treatment adherence for treatment of HCV.
Measured: Index, Post intervention, and 1 year follow-up
Secondary outcomes (2)
Better management of substance abuse and other psychiatric disorders.
Measured: Index, Post intervention, and 1 year follow up
Better social functioning and increased quality of life.
Measured: Index, Post intervention, and 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2008 (estimated)
- Study startSep 2006
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 556 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Carol S North, MD, MPE, Principal investigator, Univeristy of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598416
- Sponsor's protocol ID
- NIAAA-NORTH-AA015201
- Other IDs
- R01AA015201
- Status last verified
- Nov 2014
- First submitted
- 10 Jan 2008
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychoeducation for HCV and Alcohol Behaviors
- ClinicalTrials.gov ID
- NCT00598416
- Acronym / sponsor ID
- NIAAA-NORTH-AA015201
- Conditions
- Hepatitis C, Substance Abuse
- Keywords
- Hepatitis C, Substance Abuse, Psychoeducation, Psychiatric functioning, Physical Functioning, Quality of Life, NIAAA, Alcohol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- Sep 2006
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 21 Jan 2008 (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.
The proposed project will apply a unique, effective family-responsive psychoeducation program, PsychoEducation Responsive to Families (PERF), for Hepatitis C Virus (HCV) treatment. The goal is to demonstrate that the intervention will enlarge the eligibility of some patients for HCV treatment and help sustain others through it.
Detailed description
This study aims to evaluate the utility of a psychosocial intervention (PsychoEducation Responsive to Families; PERF), applied to help patients prepare for and sustain HCV treatment in the treatment setting. Through careful psychiatric diagnosis and multiple longitudinal assessments, this study will also shed further light on the course of comorbid alcohol use, drug use, and other psychiatric syndromes and their interrelationships. The proposed study combines an innovative psychoeducation program with traditional HCV patient care and education. The goal of this work is to improve treatment adherence, allowing individual drug regimens to achieve their optimal effectiveness and reach a wider patient population. Support and sustenance of patients from a psychosocial perspective while they are in treatment should also help deliver more patients to sustained suppression of HCV as well as help presently untreated patients and populations become candidates for this therapy-ultimately reducing the disease burden of increasing numbers of patients needing liver transplantation or facing imminent death.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation | Experimental | Behavioral: Family-Responsive Psychoeducation Program (PERF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals who are seropositive for HCV as determined by ELISA test and confirmed by direct measure of viral load as part of their clinical care
- Lack progressive or decompensated liver functions (manifest in jaundice, ascites, variceal bleeding, hepatic encephalopathy)
- Age at least 18 years
- Identified family member(s)/significant other(s) also willing to participate in the psychoeducation groups, and
- Ability to provide informed consent for research participation. "Family" will be defined to include biological relatives, as well as any non-biological individual or significant other considered "family" by either the ill member or his/her immediate family.
Key exclusion criteria (3 listed)
- Inability to provide informed consent such as irreversible cognitive impairment precluding participation
- Progressive or decompensated liver functions (manifest in jaundice, ascites, variceal bleeding, hepatic encephalopathy), and
- Age <18 years.
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-Responsive Psychoeducation Program (PERF)Group psychoeducation for HCV patients and their primary caregiver. | Behavioural | Psychoeducation |
Primary outcome
Increased treatment readiness and better treatment adherence for treatment of HCV.
Time frame: Index, Post intervention, and 1 year follow-up
2 secondary outcomes
Better management of substance abuse and other psychiatric disorders.
Time frame: Index, Post intervention, and 1 year follow up
Better social functioning and increased quality of life.
Time frame: Index, Post intervention, and 1 year follow up
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 4 Nov 2014.
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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.
Carol S North, MD, MPE principal investigator
Univeristy of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-Responsive Psychoeducation Program (PERF) in people with Hepatitis C and Substance Abuse, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site 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 5 inclusion and 3 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 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Increased treatment readiness and better treatment adherence for treatment of HCV. (time frame: Index, Post intervention, and 1 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2014.