NCT05503394

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

August 31, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2023

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

August 14, 2022

Last Update Submit

August 15, 2023

Conditions

Biliary Atresia Congenital Type 3

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The anxiety scores in primary caregivers

    At the one month after the surgical kasai portoenterostomy

Study Arms (2)

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

Behavioral: Peer support WeChat platform interventionBehavioral: 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

Behavioral: Routine nursing care group

Interventions

Peer support WeChat platform interventionBEHAVIORAL

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.

Peer support WeChat platform intervention group
Routine nursing care groupBEHAVIORAL

Provide routine inpatient education and post-discharge follow-up to primary caregivers of biliary atresia.

Peer support WeChat platform intervention groupRoutine nursing care group

Eligibility Criteria

Age1 Month - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's hospital of Fudan University

Shanghai, Shanghai Municipality, 201100, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2022

First Posted

August 16, 2022

Study Start

August 31, 2022

Primary Completion

August 10, 2023

Study Completion

August 10, 2023

Last Updated

August 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)