The Effect of Telenursing on Self-efficacy and Treatment Adherence in Children With Cystic Fibrosis

NCT ID: NCT06660745

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-20
• Study Completion Date: 2023-09-21

Brief Summary

The goal of this clinical trial is to learn if a telenursing-based programs works to increase self-efficacy and treatment adherence in children with Cystic fibrosis disease. It will also learn about the innovation and safety of this intervention.

Researchers will compare a group that received telenursing to a group with routine care to see if telenursing works to change the severity of cystic fibrosis (by changing behaviors).

Participants will be 25 in each group and were recruited during routine outpatient clinic visits in Mofid Children's Hospital during the period from April 2023 to October 2023. The participant information and consent form were provided during the first face-to-face meeting with the children and their caregivers. The patients were assigned to the intervention and control groups randomly, based on their medical record numbers, with even numbers placed in the intervention group and odd numbers in the control group. The selected communication platform (Skype) was installed by the researcher on the caregiver's and, if available, the child's mobile devices. The members of the intervention group were then added to a group called "Cystic Fibrosis Companions," which was created by the researcher on Skype. Patients in the control group continued with routine treatment and follow-up (monthly visits to the cystic fibrosis clinic and prescribed medications). For the intervention group, a telenursing-based program and follow-up were planned twice a week over twelve weeks. The intervention content for this study was derived from www.cff.org and www.cfsource.com websites and was developed by the research team. The content included topics related to various aspects of the disease and its management, Adjusting and moderating the physical activity program, medication regimen, Nutrition, and mental health. The intervention was conducted in two sections. The first part included a one-day educational workshop conducted through Skype for the child and their caregiver and was planned to introduce the members of the intervention group to each other and provide information on how to deliver and receive the content. In the second part of the intervention, the content was prepared based on a scheduled plan. It was in the form of a 5-10-minute audio file, video, or educational text and was uploaded on the SendBig website. Once the upload is complete, a link is provided to the user. The link was sent to the phone numbers of children with cystic fibrosis and their caregivers so that they could watch the weekly content over three months. Once it was confirmed that the link had been received (acknowledged in the "Cystic Fibrosis Companions" group) and the content had been viewed, remote follow-ups were scheduled twice a week, on Sundays and Tuesdays between 6:00 PM and 8:00 PM, using Skype messenger. During these sessions, the researcher reviewed the content sent that week and addressed any questions that the child and caregiver might have had about the content. These sessions also encourage interaction among the children, allow sharing of experiences gained from the interventions within each family, and allow feedback to be received. In order to prevent the control group from finding out about the content sent to the intervention group, a separate group with a different title was created on Skype, and all members of the control group were added to this new group. At the end of week 12, after the intervention was completed, the PRCISE and MATQ questionnaires were sent to the child's or caregiver's account and were completed in both control and intervention groups. Additionally, 4 weeks after the intervention, the same two questionnaires were completed again by both groups and finally, the results of the two groups were compared. At the end of the study, to observe ethical considerations, all contents were provided to the control group in the form of a compressed file containing videos, images, audio, and booklets. In this study, the mean age of the children was 12.24 in the intervention group, and 12.36 in the control group, 56% of the children with CF were boys, and 50% of them were in elementary school. A comparison of self-efficacy and treatment adherence scores indicated that the mean scores in the intervention and control groups were significantly different before and after the intervention, showing an increase immediately and one month after the intervention

Conditions

Cystic Fibrosis in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

Intervention Group includes 25 children and their caregivers. interventional content with educational-practical and care-support model is in the form of an audio-visual file or an educational text (5-10 minutes) within a period of three months and through the content link (Send Big website) to the email address or number. It will be sent to teenager or caregiver of children with Cystic fibrosis, and after observation, remote follow-up will be done twice a week on the Skype platform, and the researcher will answer All of the questions that relate to contents. The content included topics related to various aspects of the disease and its management, Adjusting and moderating the physical activity program, medication regimen, Nutrition, and mental health.

Group Type: EXPERIMENTAL

telenursing-based family empowerment program

Intervention Type: OTHER

The intervention was conducted in two sections. The first part included a one-day educational workshop conducted through Skype for the child and their caregiver and was planned to introduce the members of the intervention group to each other and provide information on how to deliver and receive the content. In the second part of the intervention, the content was prepared based on a scheduled plan. It was in the form of a 5-10-minute audio file, video, or educational text and was uploaded on the SendBig website. Once the upload is complete, a link is provided to the user. The link was sent to the phone numbers of children with cystic fibrosis and their caregivers so that they could watch the weekly content over three months. Once it was confirmed that the link had been received (acknowledged in the "Cystic Fibrosis Companions" group) and the content had been viewed, remote follow-ups were scheduled twice a week, on Sundays and Tuesdays between 6:00 PM and 8:00 PM, using Skype messenger.

Control group

in control group, No intervention will take place and the patients will receive their routine treatment plan.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

telenursing-based family empowerment program

The intervention was conducted in two sections. The first part included a one-day educational workshop conducted through Skype for the child and their caregiver and was planned to introduce the members of the intervention group to each other and provide information on how to deliver and receive the content. In the second part of the intervention, the content was prepared based on a scheduled plan. It was in the form of a 5-10-minute audio file, video, or educational text and was uploaded on the SendBig website. Once the upload is complete, a link is provided to the user. The link was sent to the phone numbers of children with cystic fibrosis and their caregivers so that they could watch the weekly content over three months. Once it was confirmed that the link had been received (acknowledged in the "Cystic Fibrosis Companions" group) and the content had been viewed, remote follow-ups were scheduled twice a week, on Sundays and Tuesdays between 6:00 PM and 8:00 PM, using Skype messenger.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• child's fluency in speaking, writing, and reading Farsi
• having a confirmed diagnosis of CF by a specialist
• having been diagnosed for at least one year
• not having any mental, or cognitive disorders or any other chronic diseases
• not have speech, hearing, or vision problems
• live with both parents
• have access to a smartphone
• be able to connect to the internet and send voice and text via Skype

Exclusion Criteria

• had a Lack of interest in continuing the study
• recent pulmonary exacerbation or hospitalization during the intervention
• unable to follow educational sessions and provide feedback in at least two Q&A sessions

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Azam Shirinabadi Farahani

Director, Correspondent Author, member of the Pediatrics Department, Principal Investigator, Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Azam Shirinabadi Farahani, PhD

Role: STUDY_DIRECTOR

PhD in Nursing, Associated Professor, Department of Pediatrics Nursing, School of Nursing & Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Locations

Mofid Children Hospital

Tehran, , Iran

Countries

Iran

Other Identifiers

IRCT20230717058822N1

Identifier Type: REGISTRY

Identifier Source: secondary_id

IR.SBMU.PHARMACY.REC.1401.280

Identifier Type: -

Identifier Source: org_study_id