Condition category
Digestive System
Date applied
09/03/2020
Date assigned
11/03/2020
Last edited
09/04/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

Plain English Summary

Background and study aims
Diarrhea and vomiting in children is a common reason for parents to take their child to the emergency department. There has been a lot of research on how to treat children with diarrhea and vomiting in the emergency department. There are also things parents can do at home to help their children when they have diarrhea and vomiting. Some of these things could help avoid a trip to the emergency department. It is important that parents are aware of this information so they can make the best decisions for their children’s health. The researchers have made a short video with parent input to tell them about how to manage a child with diarrhea and vomiting. It is important to test this video to make sure that it helps parents before we make the video widely available. In this project, parents will help us test the video.

Who can participate?
Parent or caregiver of a child 16 years or younger presenting to the emergency department with vomiting and diarrhea.

What does the study involve?
Parents who come to the emergency department with a child who has diarrhea and vomiting will be invited to participate in the study. They will be randomized to view the video or a sham video. Then they will answer some questions. Parents who watch the video will also be invited to participate in an interview. The questionnaires and interview will help us understand if the video works and if parents find the video helpful. The researchers will also ask parents about how they found the study process, including the use of an electronic, web-based platform to collect data. This will help to understand whether parents are willing to participate in similar research in the future.

What are the possible benefits and risks of participating?
None

Where is the study run from?
Stollery Children's Hospital (Canada)

When is the study starting and how long is it expected to run for?
April 2020 to March 2021

Who is funding the study?
Canadian Institutes of Health Research

Who is the main contact?
Dr Lisa Hartling
hartling@ualberta.ca

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lisa Hartling

ORCID ID

Contact details

ECHA 4-472
1405 87 Avenue
Edmonton
T6G 1C9
Canada
+1 7804 926124
hartling@ualberta.ca

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Pro00091675

Study information

Scientific title

A pilot and feasibility randomized trial of a knowledge translation tool for parents

Acronym

Study hypothesis

The primary objective is to evaluate the potential effectiveness of a digital knowledge translation tool for parents about acute gastroenteritis. Another key objective is to examine the feasibility of using an electronic, web-based platform for intervention delivery and data collection.

Ethics approval

Approved 16/08/2019, University of Alberta Health Research Ethics Board (Research Ethics Office, 308 Campus Tower, 8625 – 112 Street, Edmonton, AB T6G 1K8, Canada; +1 780 492 0459; reoffice@ualberta.ca), ref: Pro00091675

Study design

Single-centre pilot and feasibility randomized trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Acute gastroenteritis

Intervention

Participants will be randomly allocated to intervention or control groups.

The intervention is a 3-minute whiteboard animation video about acute gastroenteritis. The sham control is a 3-minute video about handwashing produced by the US Centres for Disease Control. The participants (i.e., parents or caregivers of children with gastroenteritis) will watch the video to which they are randomized once while waiting in the emergency department; they will have an option to be sent a link to the video by email after having watched it. At the end of the study, all participants will be sent a link to both videos that were used in the study.

The intervention/control is 3 minutes in duration. Participants are asked to complete three questionnaires. The first questionnaire is completed before the intervention. The second questionnaire is completed immediately after the intervention. The third questionnaire is sent to participants by email 4 days after entering the study. They will have up to 14 days following entry into the study to complete the third questionnaire. Participants in the intervention group are also invited to participate in a qualitative interview about the perceived benefit and value of the video, and study processes (e.g., the use of the electronic, web-based platform for intervention delivery and data collection).

The randomization sequence will be computer generated and will be kept confidential. Participants, research staff, and study investigators will not know the randomization sequence. Randomization, based on the computer generated sequence, will be deployed within the web-based platform. The video to which participants are randomized will automatically begin to play after they complete the first questionnaire. Participants will be blinded to the interventions being compared. Study investigators and the statistician will be blinded to group allocation.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Potential effectiveness will be assessed based on parent knowledge, decision regret, healthcare utilization, perceived benefit and utility of the intervention. All outcomes will be based on participant self-reports and collected through questionnaires completed by the participants.
1. Parent knowledge is based on 8 questions about acute gastroenteritis (informed by the Caregiver Gastroenteritis Knowledge Questionnaire); these questions will be asked at baseline, immediately after the intervention, and at follow-up (4-14 days post-intervention)
2. Parent decision regret is based on the Decision Regret Scale which consists of 5 items; these questions will be asked at baseline, immediately after the intervention, and at follow-up (4-14 days post-intervention)
3. Healthcare utilization includes two items about whether the participant returned to the emergency department or visited another healthcare provider because of their child's gastroenteritis; these questions will be asked at follow-up (4-14 days post-intervention
4. For perceived benefit and utility of the intervention, participants will answer 2 questions immediately after the intervention, and 5 questions at follow-up (4-14 days post-intervention). Participants who were randomized to the whiteboard animation video will be invited for a qualitative interview which will follow a semi-structured guide with 15 questions about their perceptions of the intervention and study processes. The interview will be conducted after the participant completes the follow-up questionnaire.

Secondary outcome measures

Feasibility of using an electronic, web-based platform for intervention delivery and data collection measured using data completion from the above measures and participant experience measured using qualitative interviews as above.

Overall trial start date

21/05/2019

Overall trial end date

31/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Parent or caregiver of a child 16 years or younger
2. Child is presenting to the emergency department with vomiting and diarrhea
3. Parent is fluent in English
4. Parent is willing to be contacted for follow-up data collection

Participant type

Carer

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Child has significant chronic gastrointestinal problem or inflammatory bowel disease (i.e., Crohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis, chronic constipation)
2. Child is taking immunosuppressive therapy or has known history of immunodeficiency
3. Child has undergone oral or gastrointestinal surgery within the preceding 7 days
4. Child has had a prior visit to the emergency department for vomiting and diarrhea within the preceding 14 days

Recruitment start date

01/04/2020

Recruitment end date

31/03/2021

Locations

Countries of recruitment

Canada

Trial participating centre

Stollery Children's Hospital
8440 112 St NW
Edmonton
T6G 2B7
Canada

Sponsor information

Organisation

University of Alberta

Sponsor details

116 St & 85 Ave
Edmonton
T6G 2R3
Canada
+1 780-492-3111
general.inquiries@ualberta.ca

Sponsor type

University/education

Website

https://www.ualberta.ca

Funders

Funder type

Government

Funder name

Canadian Institutes of Health Research

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR, IRSC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Canada

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

01/01/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2018 protocol in https://www.ncbi.nlm.nih.gov/pubmed/30123522 (added 11/03/2020)

Publication citations

Additional files

Editorial Notes

09/04/2020: Due to current public health guidance, recruitment for this study has been paused. 11/03/2020: Trial’s existence confirmed by The University of Alberta