Biliary Atresia Congenital Type 3NCT05503394
A Peer Support Network System Construction for the Primary Caregivers of Children With Biliary Atresia
A study testing Peer support WeChat platform intervention and Routine nursing care group in people with Biliary Atresia Congenital Type 3, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
The peer support WeChat platform for primary caregivers of children with biliary atresia can provide social support ,help them adopt positive coping styles to face the disease, and reduce negative emotions and caregiver burden. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Biliary Atresia Congenital Type 3
- What is being tested?
- Peer support WeChat platform intervention and Routine nursing care group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2022to 10 Aug 2023
- 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 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child was diagnosed with biliary atresia congenital type 3 and required kasai portoenterostomy ;
- Providing primary care for the child;
- Use a smartphone and have access to the internet;
- Normal communication ability;
- Volunteering to participate in the study.
Who cannot join
- Existing or previous mental illness;
- Presence of severe anxiety (SAS ≥ 70 points) or depressive mood (SDS ≥ 70 points);
- Children with comorbidities other than biliary atresia;
- Refusal to cooperate.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's hospital of Fudan University
Shanghai, Shanghai Municipality, 201100
About this study
Official title: A Peer Support Network System Construction for the Primary Caregivers of Children With Biliary Atresia Based on Social Support Theory: A Quasi-experimental Study
The peer support WeChat platform for primary caregivers of children with biliary atresia can provide social support ,help them adopt positive coping styles to face the disease, and reduce negative emotions and caregiver burden.
Read the detailed description
The primary caregivers of children with biliary atresia have a heavy psychological burden, but there is a lack of supportive research on this population. Therefore, this study used a web-based peer support platform to intervene in the primary caregivers of children with biliary atresia to reduce the psychological burden of this population.
The study consisted of two parts. First, a literature analysis, semi-structured interviews, and expert validation are used to form a peer support WeChat platform for primary caregivers of children with biliary atresia.
Second, primary caregivers of children with biliary atresia are selected as the study population and divided into intervention and control groups in chronological order at a children's hospital in Shanghai. Primary caregivers who visit the hospital between August 2022 and October 2022 are assigned to the control group and primary caregivers who visit the hospital between January 2023 and March 2023 are assigned to the intervention group. The intervention group receives a peer support WeChat platform intervention on top of usual care from the day of surgery to one postoperative month. The levels of negative emotions and caregiver burden are compared between the two groups after the intervention.
- Conditions
- Biliary Atresia Congenital Type 3
- Being tested
- Peer support WeChat platform intervention, Routine nursing care group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer support WeChat platform interventionBehavioural
Primary caregivers of children with biliary atresia are selected as the study population and divided into intervention and control groups in chronological order at a children's hospital in Shanghai. Primary caregivers who visit the hospital between August 2022 and October 2022 are assigned to the control group and primary caregivers who visit the hospital between January 2023 and March 2023 are assigned to the intervention group. The intervention group will receive a peer support WeChat platform intervention from the day of surgery to one month postoperatively. The level of negative emotions and caregiver burden will be compared between the two groups after the intervention. The intervention group receives the same routine care as the control group.
Routine nursing care groupBehavioural
Provide routine inpatient education and post-discharge follow-up to primary caregivers of biliary atresia.
| Study group | Role | What they receive |
|---|---|---|
| Peer support WeChat platform intervention group | Experimental | Peer support WeChat platform intervention for primary caregivers of children with biliary atresia based on routine care during the postoperative period up to one month postoperatively Receives: Behavioral: Peer support WeChat platform intervention; Behavioral: Routine nursing care group |
| Routine nursing care group | Other | Perform routine nursing care for primary caregivers of children with biliary atresia during the postoperative period up to one month postoperatively Receives: Behavioral: Routine nursing care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The depression scores in primary caregivers
At the one month after surgical kasai portoenterostomy, primary caregivers' depression scores will be measured using the self-rating depression scale (SDS) by a specially-assigned person. The SDS has a total of 20 items, and the score ranges from 25 to 100 points. The higher the score and the more severe the depression.
Measured: At the one month after the surgical kasai portoenterostomy
Secondary outcomes (1)
The anxiety scores in primary caregivers
At the one month after surgical kasai portoenterostomy, primary caregivers' anxiety scores will be measured using the self-rating anxiety scale (SAS) by a specially-assigned person. The SAS has a total of 20 items, and the score ranges from 25 to 100 points. The higher the score and the more severe the anxiety .
Measured: At the one month after the surgical kasai portoenterostomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start31 Aug 2022
- Primary completion10 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Atresia Congenital Type 3Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503394
- Sponsor's protocol ID
- 2021390
- Status last verified
- Aug 2023
- First submitted
- 14 Aug 2022
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Peer Support Network System Construction for the Primary Caregivers of Children With Biliary Atresia Based on Social Support Theory: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT05503394
- Acronym / sponsor ID
- 2021390
- Conditions
- Biliary Atresia Congenital Type 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 16 Aug 2022 (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 peer support WeChat platform for primary caregivers of children with biliary atresia can provide social support ,help them adopt positive coping styles to face the disease, and reduce negative emotions and caregiver burden.
Detailed description
The primary caregivers of children with biliary atresia have a heavy psychological burden, but there is a lack of supportive research on this population. Therefore, this study used a web-based peer support platform to intervene in the primary caregivers of children with biliary atresia to reduce the psychological burden of this population.
The study consisted of two parts. First, a literature analysis, semi-structured interviews, and expert validation are used to form a peer support WeChat platform for primary caregivers of children with biliary atresia.
Second, primary caregivers of children with biliary atresia are selected as the study population and divided into intervention and control groups in chronological order at a children's hospital in Shanghai. Primary caregivers who visit the hospital between August 2022 and October 2022 are assigned to the control group and primary caregivers who visit the hospital between January 2023 and March 2023 are assigned to the intervention group. The intervention group receives a peer support WeChat platform intervention on top of usual care from the day of surgery to one postoperative month. The levels of negative emotions and caregiver burden are compared between the two groups after the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer support WeChat platform intervention group | Experimental | Behavioral: Peer support WeChat platform intervention, Behavioral: Routine nursing care groupPeer support WeChat platform intervention for primary caregivers of children with biliary atresia based on routine care during the postoperative period up to one month postoperatively |
| Routine nursing care group | Other | Behavioral: Routine nursing care groupPerform routine nursing care for primary caregivers of children with biliary atresia during the postoperative period up to one month postoperatively |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Child was diagnosed with biliary atresia congenital type 3 and required kasai portoenterostomy ;
- Providing primary care for the child;
- Use a smartphone and have access to the internet;
- Normal communication ability;
- Volunteering to participate in the study.
Key exclusion criteria (4 listed)
- Existing or previous mental illness;
- Presence of severe anxiety (SAS ≥ 70 points) or depressive mood (SDS ≥ 70 points);
- Children with comorbidities other than biliary atresia;
- Refusal to cooperate.
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 |
|---|---|---|
| Peer support WeChat platform interventionPrimary caregivers of children with biliary atresia are selected as the study population and divided into intervention and control groups in chronological order at a children's hospital in Shanghai. Primary caregivers who visit the hospital between August 2022 and October 2022 are assigned to the control group and primary caregivers who visit the hospital between January 2023 and March 2023 are assigned to the intervention group. The intervention group will receive a peer support WeChat platform intervention from the day of surgery to one month postoperatively. The level of negative emotions and caregiver burden will be compared between the two groups after the intervention. The intervention group receives the same routine care as the control group. | Behavioural | Peer support WeChat platform intervention group |
| Routine nursing care groupProvide routine inpatient education and post-discharge follow-up to primary caregivers of biliary atresia. | Behavioural | Peer support WeChat platform intervention group, Routine nursing care group |
Primary outcome
The depression scores in primary caregivers
Time frame: At the one month after the surgical kasai portoenterostomy
At the one month after surgical kasai portoenterostomy, primary caregivers' depression scores will be measured using the self-rating depression scale (SDS) by a specially-assigned person. The SDS has a total of 20 items, and the score ranges from 25 to 100 points. The higher the score and the more severe the depression.
1 secondary outcome
The anxiety scores in primary caregivers
Time frame: At the one month after the surgical kasai portoenterostomy
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 18 Aug 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer support WeChat platform intervention and Routine nursing care group in people with Biliary Atresia Congenital Type 3, run by Children's Hospital of Fudan University at 1 site in China.
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 4 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 18 Aug 2023. 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 China. 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?
The depression scores in primary caregivers (time frame: At the one month after the surgical kasai portoenterostomy). 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 18 Aug 2023.