CaregiversNCT04205396
CAREGIVER: A Trial to Improve the Burden and Distress of Caring for Persons With Decompensated Cirrhosis
A study testing Written emotional disclosure, Resilience training and No treatment in people with Caregivers, run by University of Michigan at 1 site in United States.
Trial summary
The goal of this study is to enroll caretakers of patients with decompensated cirrhosis to determine if written emotional disclosure or resilience training interventions reduce distress and burden among primary informal caregivers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregivers
- What is being tested?
- Written emotional disclosure, Resilience training and No treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2020to 22 Mar 2022
- 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
- Primary informal caregiver for a patient with a clinical diagnosis of decompensated cirrhosis with either of the following three clinical criteria:
- Child-Turcotte Pugh (CTP) Class A/B/C cirrhosis with an all cause hospitalization within the previous 30 days.
- CTP Class B or C cirrhosis with one of the following within the prior 6 months from the date of enrollment:
- Ascites (requiring paracentesis or diuretics)
- Overt Hepatic Encephalopathy (requiring lactulose or rifaximin/flagyl/neomycin)
- Spontaneous Bacterial Peritonitis (SBP)
Show all 11Show fewer
- Hepatic Hydrothorax (requiring diuretics or thoracentesis)
- Variceal Bleed (with 1 or more recurrences)
- Hepatocellular Carcinoma (HCC)
- Any Barcelona Clinic Liver Cancer (BCLC) Stage with CTP Class B or C
- BCLC Stage C or D with CTP Class A
Who cannot join
- Non-English speaking
- Unable or unwilling to provide verbal consent
- Severe cognitive impairment
- Caregiver is participating in another interventional study
- Caregiver has used a personal diary within the past 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: CAREGIVER: An Randomized Clinical Trial (RCT) to Improve the Burden and Distress of Caring for Persons With Decompensated Cirrhosis
The goal of this study is to enroll caretakers of patients with decompensated cirrhosis to determine if written emotional disclosure or resilience training interventions reduce distress and burden among primary informal caregivers.
Caretakers that meet eligibility will complete baseline assessments in person, or if necessary, over the phone and be randomized to be in one of three arms of this study. Materials specific to each study arm will be mailed to the caretakers home along with instructions. Overall, the study will take approximately 2 months and a qualitative interview will also be completed around 3-6 months post-baseline.
- Conditions
- Caregivers
- Being tested
- Written emotional disclosure, Resilience training, No treatment
- Keywords
- cirrhosis, hepatic encephalopathy, ascites, varices, liver disease, resilience training, expressive writing
- Medical subject headings
- Fibrosis, Hepatic Encephalopathy, Ascites, Varicose Veins, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written emotional disclosureBehavioural
Participants will write five stories (days 8, 11, 14, 17 and 20) about an assigned topic relating to their experiences as a caregiver of someone with advanced liver disease. Rules for the exercise will be provided in an instructions page. Additionally, baseline and outcome measures will be completed.
Resilience trainingBehavioural
Participants will write three things that went well at the end of their day (before going to sleep), and what was their role in bringing them. These will be done about every three days (days 8, 11, 14, 17 and 20) for 2 weeks at home. Rules for the exercise will be provided in an instructions page. Additionally, baseline and outcome measures will be completed.
No treatmentOther
Participants will complete baseline and outcome assessments and no intervention will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| Written emotional disclosure | Experimental | Not described Receives: Behavioral: Written emotional disclosure |
| Resilience training | Experimental | Not described Receives: Behavioral: Resilience training |
| Control arm | Other | Not described Receives: Other: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in burden of caregivers measured using the Zarit Burden Interview (ZBI -12)
The short form of the ZBI is a validated short 12-item questionnaire measuring perceived burden associated with care giving. Participants rate each item on a 5-point scale ranging from 0 (never) to 4 (nearly always) the range of possible score is 0 (less burden) to 48 (more burden).
Measured: At baseline and then at 4 week and 8 weeks
Secondary outcomes (3)
Change in Visual Analogue Score (VAS)
The VAS is a measure of health related quality of life (HRQOL). It is a scale from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Measured: At baseline and then at 4 week and 8 weeks
Change in Distress Thermometer (DT)
This is a single-item self-report measure of distress. The DT is presented as a 10-point scale in a thermometer format and asks to rate how distressed one felt in the previous week from 0 (not distressed) to 10 (extremely distressed).
Measured: At baseline and then at 4 week and 8 weeks
Change in Caregiver Captivity Index (CCI)
A three-item self-report measure of how much (very much, somewhat, just a little, not at all) a caregiver feels like a captive, or being an unwilling or involuntary incumbent of a caregiver role. Scored on a scale of 4-12 with higher scores being worse
Measured: At baseline and then at 4 week and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start10 Feb 2020
- Primary completion22 Mar 2022
- Study completion22 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CaregiversStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elliot B. Tapper, University of Michigan
- Investigators
- Elliot Tapper, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205396
- Sponsor's protocol ID
- HUM00167479
- Status last verified
- Apr 2022
- First submitted
- 17 Dec 2019
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tapper EB, Saleh ZM, Lizza S, Chen X, Nikirk S, Serper M. CAREGIVER Randomized Trial of Two Mindfulness Methods to Improve the Burden and Distress of Caring for Persons with Cirrhosis. Dig Dis Sci. 2023 Sep;68(9):3625-3633. doi: 10.1007/s10620-023-08042-9. Epub 2023 Jul 27.
PubMed 37498415
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAREGIVER: An Randomized Clinical Trial (RCT) to Improve the Burden and Distress of Caring for Persons With Decompensated Cirrhosis
- ClinicalTrials.gov ID
- NCT04205396
- Acronym / sponsor ID
- HUM00167479
- Conditions
- Caregivers
- Keywords
- cirrhosis, hepatic encephalopathy, ascites, varices, liver disease, resilience training, expressive writing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 19 Dec 2019 (actual)
- 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 goal of this study is to enroll caretakers of patients with decompensated cirrhosis to determine if written emotional disclosure or resilience training interventions reduce distress and burden among primary informal caregivers.
Caretakers that meet eligibility will complete baseline assessments in person, or if necessary, over the phone and be randomized to be in one of three arms of this study. Materials specific to each study arm will be mailed to the caretakers home along with instructions. Overall, the study will take approximately 2 months and a qualitative interview will also be completed around 3-6 months post-baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Written emotional disclosure | Experimental | Behavioral: Written emotional disclosure |
| Resilience training | Experimental | Behavioral: Resilience training |
| Control arm | Other | Other: No treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Primary informal caregiver for a patient with a clinical diagnosis of decompensated cirrhosis with either of the following three clinical criteria:
Key exclusion criteria (5 listed)
- Non-English speaking
- Unable or unwilling to provide verbal consent
- Severe cognitive impairment
- Caregiver is participating in another interventional study
- Caregiver has used a personal diary within the past 12 months
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 |
|---|---|---|
| Written emotional disclosureParticipants will write five stories (days 8, 11, 14, 17 and 20) about an assigned topic relating to their experiences as a caregiver of someone with advanced liver disease. Rules for the exercise will be provided in an instructions page. Additionally, baseline and outcome measures will be completed. | Behavioural | Written emotional disclosure |
| Resilience trainingParticipants will write three things that went well at the end of their day (before going to sleep), and what was their role in bringing them. These will be done about every three days (days 8, 11, 14, 17 and 20) for 2 weeks at home. Rules for the exercise will be provided in an instructions page. Additionally, baseline and outcome measures will be completed. | Behavioural | Resilience training |
| No treatmentParticipants will complete baseline and outcome assessments and no intervention will be conducted. | Other | Control arm |
Primary outcome
Change in burden of caregivers measured using the Zarit Burden Interview (ZBI -12)
Time frame: At baseline and then at 4 week and 8 weeks
The short form of the ZBI is a validated short 12-item questionnaire measuring perceived burden associated with care giving. Participants rate each item on a 5-point scale ranging from 0 (never) to 4 (nearly always) the range of possible score is 0 (less burden) to 48 (more burden).
3 secondary outcomes
Change in Visual Analogue Score (VAS)
Time frame: At baseline and then at 4 week and 8 weeks
Change in Distress Thermometer (DT)
Time frame: At baseline and then at 4 week and 8 weeks
Change in Caregiver Captivity Index (CCI)
Time frame: At baseline and then at 4 week and 8 weeks
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 15 Apr 2022.
- Derived from this study: PubMed 37498415Tapper EB, Saleh ZM, Lizza S, Chen X, Nikirk S, Serper M. CAREGIVER Randomized Trial of Two Mindfulness Methods to Improve the Burden and Distress of Caring for Persons with Cirrhosis. Dig Dis Sci. 2023 Sep;68(9):3625-3633. doi: 10.1007/s10620-023-08042-9. Epub 2023 Jul 27.
- Individual participant dataSharing planned: No
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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.
Elliot Tapper, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written emotional disclosure, Resilience training and No treatment in people with Caregivers, run by University of Michigan 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 11 inclusion and 5 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 15 Apr 2022. 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?
Change in burden of caregivers measured using the Zarit Burden Interview (ZBI -12) (time frame: At baseline and then at 4 week and 8 weeks). 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 NCT04205396, which also lists 1 linked publication.
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 15 Apr 2022.