Cystic Fibrosis in ChildrenNCT06660745
The Effect of Telenursing on Self-efficacy and Treatment Adherence in Children With Cystic Fibrosis
A study testing telenursing-based family empowerment program in people with Cystic Fibrosis in Children, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Cystic Fibrosis in Children
- What is being tested?
- telenursing-based family empowerment program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- 20 May 2023to 21 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Telenursing-based Family Empowerment Program on Self-efficacy and Treatment Adherence in Children With Cystic Fibrosis
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
- Being tested
- telenursing-based family empowerment program
- Keywords
- Telenursing, Self-efficacy, Treatment adherence, Children, Cystic Fibrosis
- Medical subject headings
- Treatment Adherence and Compliance, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telenursing-based family empowerment programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: telenursing-based family empowerment program |
| Control group | No intervention | in control group, No intervention will take place and the patients will receive their routine treatment plan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Rating of Chronic Illness Self-efficacy (PRCISE)
The Pediatric Rating of Chronic Illness Self-Efficacy scale (PRCISE) was developed by Emerson et al. (2018), to investigate the level of self-efficacy in children with chronic illnesses (20), which was reevaluated and edited by the developers in the same year and finalized with 15 items. The questionnaire was scored on an 11-point Likert scale, with zero and 150 being the minimum and maximum scores, respectively. Zero is equivalent to no self-efficacy and 150 indicates the best possible self-efficacy.
Measured: Before the intervention, immediately after and 4 weeks after the intervention
Secondary outcomes (1)
The Modanloo Adherence to Treatment Questionnaire (MATQ)
examine the level of adherence to treatment in patients with chronic disease (24), which consists of 40 items with 7 dimensions. The questionnaire was scored on a 6-point Likert scale, ranging from "Completely" with a score of 5 to "Not at all" with a score of 0. Some items are reverse-scored. The obtained scores fall between 0 and 200, and higher scores indicate better treatment adherence.
Measured: Before the intervention, immediately after and 4 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start20 May 2023
- Primary completion21 Sep 2023
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 50 children and adolescents with CF aged between 9-17 participated in this study.The subjects were assigned to two groups randomly, based on their medical record numbers, with even numbers placed in the intervention group and odd numbers in the control group. intervention group received twelve-week telenursing training via the SendBig website and Skype messenger and control received routine care.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azam Shirinabadi Farahani, Shahid Beheshti University of Medical Sciences
- Investigators
- Azam Shirinabadi Farahani, PhD, Study director, PhD in Nursing, Associated Professor, Department of Pediatrics Nursing, School of Nursing & Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660745
- Sponsor's protocol ID
- IR.SBMU.PHARMACY.REC.1401.280
- Other IDs
- IRCT20230717058822N1
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Telenursing-based Family Empowerment Program on Self-efficacy and Treatment Adherence in Children With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT06660745
- Acronym / sponsor ID
- IR.SBMU.PHARMACY.REC.1401.280
- Conditions
- Cystic Fibrosis in Children
- Keywords
- Telenursing, Self-efficacy, Treatment adherence, Children, Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 20 May 2023 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 50 children and adolescents with CF aged between 9-17 participated in this study.The subjects were assigned to two groups randomly, based on their medical record numbers, with even numbers placed in the intervention group and odd numbers in the control group. intervention group received twelve-week telenursing training via the SendBig website and Skype messenger and control received routine care.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: telenursing-based family empowerment programIntervention 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. |
| Control group | No intervention | –in control group, No intervention will take place and the patients will receive their routine treatment plan. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telenursing-based family empowerment programThe 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. | Other | Intervention Group |
Primary outcome
Pediatric Rating of Chronic Illness Self-efficacy (PRCISE)
Time frame: Before the intervention, immediately after and 4 weeks after the intervention
The Pediatric Rating of Chronic Illness Self-Efficacy scale (PRCISE) was developed by Emerson et al. (2018), to investigate the level of self-efficacy in children with chronic illnesses (20), which was reevaluated and edited by the developers in the same year and finalized with 15 items. The questionnaire was scored on an 11-point Likert scale, with zero and 150 being the minimum and maximum scores, respectively. Zero is equivalent to no self-efficacy and 150 indicates the best possible self-efficacy.
1 secondary outcome
The Modanloo Adherence to Treatment Questionnaire (MATQ)
Time frame: Before the intervention, immediately after and 4 weeks after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: Yes. IPD used in the results publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azam Shirinabadi Farahani, PhD study director
PhD in Nursing, Associated Professor, Department of Pediatrics Nursing, School of Nursing & Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telenursing-based family empowerment program in people with Cystic Fibrosis in Children, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Rating of Chronic Illness Self-efficacy (PRCISE) (time frame: Before the intervention, immediately after and 4 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.