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A Peer Support Network System Construction for the Primary Caregivers of Children With Biliary Atresia

Primary Purpose

Biliary Atresia Congenital Type 3

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Peer support WeChat platform intervention
Routine nursing care group
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Biliary Atresia Congenital Type 3

Eligibility Criteria

1 Month - 12 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Children's hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Peer support WeChat platform intervention group

Routine nursing care group

Arm Description

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

Perform routine nursing care for primary caregivers of children with biliary atresia during the postoperative period up to one month postoperatively

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 .

Full Information

First Posted
August 14, 2022
Last Updated
August 15, 2023
Sponsor
Children's Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05503394
Brief Title
A Peer Support Network System Construction for the Primary Caregivers of Children With Biliary Atresia
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 31, 2022 (Actual)
Primary Completion Date
August 10, 2023 (Actual)
Study Completion Date
August 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Atresia Congenital Type 3

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer support WeChat platform intervention group
Arm Type
Experimental
Arm Description
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
Arm Title
Routine nursing care group
Arm Type
Other
Arm Description
Perform routine nursing care for primary caregivers of children with biliary atresia during the postoperative period up to one month postoperatively
Intervention Type
Behavioral
Intervention Name(s)
Peer support WeChat platform intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Routine nursing care group
Intervention Description
Provide routine inpatient education and post-discharge follow-up to primary caregivers of biliary atresia.
Primary Outcome Measure Information:
Title
The depression scores in primary caregivers
Description
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.
Time Frame
At the one month after the surgical kasai portoenterostomy
Secondary Outcome Measure Information:
Title
The anxiety scores in primary caregivers
Description
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 .
Time Frame
At the one month after the surgical kasai portoenterostomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Children's hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201100
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Peer Support Network System Construction for the Primary Caregivers of Children With Biliary Atresia

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