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

February 24, 2022 updated by: Asa Hornsten, Umeå University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
      • Örnsköldsvik, Sweden
        • Recruiting
        • Region Västernorrland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Parental Stress Scale
Time Frame: 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.
Parental stress at baseline
Parental Stress Scale
Time Frame: 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.
Change Parental stress at 4 months
Parental Stress Scale
Time Frame: 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.
Change Parental stress at 8 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
eHealth Scale
Time Frame: 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.
eHealth literacy at baseline
eHealth Scale
Time Frame: 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.
Increased eHealth literacy at 4 months
eHealth Scale
Time Frame: 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.
Increased eHealth literacy at 8 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
VAS Scale
Time Frame: 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.
Satisfaction with child health care at baseline
VAS Scale
Time Frame: 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.
Satisfaction with child health care at 4 months
VAS Scale
Time Frame: 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.
Satisfaction with child health care at 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Umeå University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Västernorrland County Council, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings