Digital Support for Parents of Children in Child Health Care (LValan)

Digital Support for Parents of Children in Child Health Care - an Evaluation of an Intervention in Primary Health Care

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.

Study Overview

• Status: Recruiting
• Conditions: Parenting; Nurse-Patient Relations; Children, Only; Health Knowledge, Attitudes, Practice; Health Care Seeking Behavior
• Intervention / Treatment: Other: Intervention, digital support

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lotha Valan, Licentiate; Phone Number: +46703248243; Email: lotha.valan@umu.se
• Study Contact Backup: Name: Åsa Hörnsten, Professor; Phone Number: +46702494636; Email: asa.hornsten@umu.se

Study Locations

• Sweden
  • Örnsköldsvik, Sweden
    • Recruiting
    • Region Västernorrland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention, digital support; Parents are offered participation in a digital channel consisting of video consultations, parental support gruops and parental education.	Other: Intervention, digital support; 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
No Intervention: Control, usual care; Usual child health care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
eHealth Scale	The eHeals scale consists of 10 questions in five ratings where 1 is "do not agree at all" and 5 "fully agree". Total scores of the eHEALS are summed to range from 8 to 40, with higher scores representing higher self-perceived eHealth literacy.	eHealth literacy at baseline
eHealth Scale	The eHeals scale consists of 10 questions in five ratings where 1 is "do not agree at all" and 5 "fully agree". Total scores of the eHEALS are summed to range from 8 to 40, with higher scores representing higher self-perceived eHealth literacy.	Increased eHealth literacy at 4 months
eHealth Scale	The eHeals scale consists of 10 questions in five ratings where 1 is "do not agree at all" and 5 "fully agree". Total scores of the eHEALS are summed to range from 8 to 40, with higher scores representing higher self-perceived eHealth literacy.	Increased eHealth literacy at 8 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS Scale	The VAS scale consists of a line with a cross marker where participants can make crosses according to a 5 degree scale in 3 different questions. The line is divided into 5 points with 1 cm distance where marking 1 from the left is graded "not at all" to the last on the right side of the line is 5 "Completely". Total scores of the VAS are summed to range from 3 to 15, with higher scores representing higher levels of degrees.	Satisfaction with child health care at baseline
VAS Scale	The VAS scale consists of a line with a cross marker where participants can make crosses according to a 5 degree scale. The line is divided into 5 points with 1 cm distance where marking 1 from the left is graded "not at all" to the last on the right side of the line is "Completely". Total scores of the VAS are summed to range from 3 to 15, with higher scores representing higher levels of degrees.	Satisfaction with child health care at 4 months
VAS Scale	The VAS scale consists of a line with a cross marker where participants can make crosses according to a 5 degree scale. The line is divided into 5 points with 1 cm distance where marking 1 from the left is graded "not at all" to the last on the right side of the line is "Completely". Total scores of the VAS are summed to range from 3 to 15, with higher scores representing higher levels of degrees.	Satisfaction with child health care at 8 months

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: Västernorrland County Council, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: UmU-2021-LValan

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