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

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.

Study Overview

• Status: Completed
• Conditions: Biliary Atresia Congenital Type 3
• Intervention / Treatment: Behavioral: Peer support WeChat platform intervention; Behavioral: Routine nursing care group

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chenglu Zhang, Master; Phone Number: +8613818249330; Email: 2512794717@qq.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201100
      • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 year (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peer support WeChat platform intervention group; 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	Behavioral: Peer support WeChat platform intervention; 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.; Behavioral: Routine nursing care group; Provide routine inpatient education and post-discharge follow-up to primary caregivers of biliary atresia.
Other: Routine nursing care group; Perform routine nursing care for primary caregivers of children with biliary atresia during the postoperative period up to one month postoperatively	Behavioral: Routine nursing care group; Provide routine inpatient education and post-discharge follow-up to primary caregivers of biliary atresia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the one month after the surgical kasai portoenterostomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .	At the one month after the surgical kasai portoenterostomy

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2022
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): August 10, 2023

Study Registration Dates

• First Submitted: August 14, 2022
• First Submitted That Met QC Criteria: August 14, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Biliary Tract Diseases; Bile Duct Diseases; Digestive System Abnormalities; Biliary Atresia
• Other Study ID Numbers: 2021390

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No