NCT05256407

Brief Summary

Becoming a parent is a life-changing event that can be both gratifying and stressful. As a parent, one is responsible for another person, where there sometimes is a need for new information, knowledge, and advice to live up to the new requirements that a changing family situation requires. The objective of this study is to develop and evaluate a new digital channel in child health care for support of parents in child health care issues with particular focus on eHealth literacy and satisfaction with care. An intervention is planned to run over eight months and will be evaluated in an intervention- and control group (from another health care centre) at baseline, 4 months and at 8 months follow-up. Data includes interviews and questionnaires about parental stress and eHealth literacy as well as satisfaction with care. Data will be analysed with qualitative and statistical methods. Expected outcomes is reduced parental stress and increased satisfaction with child health care.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

1.1 years

First QC Date

September 16, 2021

Last Update Submit

February 24, 2022

Conditions

ParentingChildren, OnlyHealth Care Seeking BehaviorHealth Knowledge, Attitudes, PracticeNurse-Patient Relations

Outcome Measures

Primary Outcomes (3)

  • Parental Stress Scale

    The scale consists of 17 questions graded from 1 to 5, where 1 indicates "Do not agree at all" and 5 is "Agree completely". A total is calculated by adding all items together to obtain a score ranging from 18 to 90, with higher scores indicating higher levels of parental stress.

    Parental stress at baseline

  • Parental Stress Scale

    The scale consists of 17 questions graded from 1 to 5, where 1 indicates "Do not agree at all" and 5 is "Agree completely". A total is calculated by adding all items together to obtain a score ranging from 18 to 90, with higher scores indicating higher levels of parental stress.

    Change Parental stress at 4 months

  • Parental Stress Scale

    The scale consists of 17 questions graded from 1 to 5, where 1 indicates "Do not agree at all" and 5 is "Agree completely". A total is calculated by adding all items together to obtain a score ranging from 18 to 90, with higher scores indicating higher levels of parental stress.

    Change Parental stress at 8 months

Secondary Outcomes (3)

  • eHealth Scale

    eHealth literacy at baseline

  • eHealth Scale

    Increased eHealth literacy at 4 months

  • eHealth Scale

    Increased eHealth literacy at 8 months

Other Outcomes (3)

  • VAS Scale

    Satisfaction with child health care at baseline

  • VAS Scale

    Satisfaction with child health care at 4 months

  • VAS Scale

    Satisfaction with child health care at 8 months

Study Arms (2)

Intervention, digital support

EXPERIMENTAL

Parents are offered participation in a digital channel consisting of video consultations, parental support gruops and parental education.

Other: Intervention, digital support

Control, usual care

NO INTERVENTION

Usual child health care.

Interventions

Intervention, digital supportOTHER

Internet based support of parents in child health care. Various options and choices includes parental education, digital meetings with child health nurse and peer groups

Intervention, digital support

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \* Swedish speaking parents with children (0-6 years) in Swedish child health care

You may not qualify if:

  • Parents who are registered at an address other than their child
  • Parents younger than 16 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Västernorrland

Örnsköldsvik, Sweden

RECRUITING

MeSH Terms

Conditions

Patient Acceptance of Health CareBehavior

Interventions

Methods

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Lotha Valan, Licentiate

CONTACT

+46703248243lotha.valan@umu.se

Åsa Hörnsten, Professor

CONTACT

+46702494636asa.hornsten@umu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: prospective case/control intervention study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 16, 2021

First Posted

February 25, 2022

Study Start

December 1, 2021

Primary Completion

December 31, 2022

Study Completion

May 31, 2023

Last Updated

February 25, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)