LValan: Digital Support for Parents of Children in Child Health Care

Sponsor
Umeå University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05256407
Collaborator
Västernorrland County Council, Sweden (Other)
400
1
2
17.9
22.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Intervention, digital support
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
prospective case/control intervention studyprospective case/control intervention study
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Digital Support for Parents of Children in Child Health Care - an Evaluation of an Intervention in Primary Health Care
Actual Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Parental Stress Scale [Parental stress at baseline]

    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.

  2. Parental Stress Scale [Change Parental stress at 4 months]

    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.

  3. Parental Stress Scale [Change Parental stress at 8 months]

    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.

Secondary Outcome Measures

  1. eHealth Scale [eHealth literacy at baseline]

    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.

  2. eHealth Scale [Increased eHealth literacy at 4 months]

    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.

  3. eHealth Scale [Increased eHealth literacy at 8 months]

    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.

Other Outcome Measures

  1. VAS Scale [Satisfaction with child health care at baseline]

    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.

  2. VAS Scale [Satisfaction with child health care at 4 months]

    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.

  3. VAS Scale [Satisfaction with child health care at 8 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Region Västernorrland Örnsköldsvik Sweden

Sponsors and Collaborators

  • Umeå University
  • Västernorrland County Council, Sweden

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Asa Hornsten, Professor, Umeå University
ClinicalTrials.gov Identifier:
NCT05256407
Other Study ID Numbers:
  • UmU-2021-LValan
First Posted:
Feb 25, 2022
Last Update Posted:
Feb 25, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 25, 2022