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Developing a Mobile Application for the Care of Children With Gastrostomy and The Effect of the Application on Gastrostomy

Primary Purpose

Neuromuscular Diseases, Gastrointestinal Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mobile Application Supported Education Program (G-MUEP)
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neuromuscular Diseases focused on measuring Care burden, Parent education, Gastrostomy, Nursing, M-health application, Self-efficacy

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: The gastrostomy was opened for the child within the last six months, The parent's willingness to participate in the study, The parent is literate in Turkish, Parental use of mobile devices, The parent has internet access, The parent has no communication barriers. Exclusion Criteria: -The parent has internet access problems.

Sites / Locations

  • Turkey

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Parents who meet the inclusion criteria will be informed about the study and invited to participate in the study. Verbal and written consent will be obtained from parents who meet the inclusion criteria and agree to participate in the study. In the pretest, the Complications Checklist, Zarit Caregiver Burden Scale, General Self-Efficacy Scale, State/Trait Anxiety Scale are completed by the parents. The mobile application will be introduced to the parents and they will be allowed to download it to their phones. Parents will be ensured to actively use the mobile application for three months. At the first month follow-up, the Complications Checklist, Zarit Caregiver Burden Scale, General Self-Efficacy Scale, State/Trait Anxiety Scale are completed by the parents. In the post-test, the Complications Checklist, Zarit Caregiver Burden Scale, General Self-Efficacy Scale, State/Trait Anxiety Scale are completed by the parents.

Parents who meet the inclusion criteria will be informed about the study and invited to participate in the study. Verbal and written consent will be obtained from parents who meet the inclusion criteria and agree to participate in the study. In the pretest, the Complications Checklist, Zarit Caregiver Burden Scale, General Self-Efficacy Scale, State/Trait Anxiety Scale are completed by the parents. At the first month follow-up, the Complications Checklist, Zarit Caregiver Burden Scale, General Self-Efficacy Scale, State/Trait Anxiety Scale are completed by the parents. In the post-test, the Complications Checklist, Zarit Caregiver Burden Scale, General Self-Efficacy Scale, State/Trait Anxiety Scale are completed by the parents.

Outcomes

Primary Outcome Measures

Complication Checklist
A complication checklist consisting of 14 items was created by the researcher to determine the gastrostomy-related complications of the child with gastrostomy by reviewing the relevant literature.
Zarit Caregiver Burden Scale
Zarit Caregiver Burden Scale was developed by Zarit, Reever and Bach Peterson in 1980. It is used to assess the distress experienced by caregivers of individuals in need of care. The scale is a Likert-type scale ranging from 1 to 5 as 'never', 'rarely', 'sometimes', 'often' or 'almost always'. Özlü, Yıldız & Aker (2009), who adapted the scale into Turkish, found the Cronbach's alpha coefficient of the scale to be 0.83 (Özlü, Yıldız, & Aker, 2009). A minimum score of zero and a maximum score of 76 can be obtained from the scale. The items in the scale are generally related to the social and emotional domain, and a high scale score indicates that the distress experienced is high.
General Self-Efficacy Scale
The General Self-Efficacy Scale, developed by Schwarzer and Jarusalem in 1995 and validated by Aypay (2010) in Turkish, consists of 10 items in total. The scale, whose response category consists of a 4-point scale, is scored as "Completely wrong = 1 point", "Somewhat correct = 2 points", "Moderately correct = 3 points", and "Completely correct = 4 points". There are no reverse items and no cut-off points in the scale. The minimum score is 10 and the maximum score is 40. As the scale score increases, perceived self-efficacy increases. The Cronbach's alpha coefficient calculated in the Turkish validity-reliability study was found to be 0.83.
State/Trait Anxiety Scale
State-Trait Anxiety Inventory will be used to measure the anxiety level of the parents. The State-Trait Anxiety Inventory was developed by Spielberger et al. (1970), translated into Turkish by Necla Öner and Le Compte in 1985, and its validity and reliability were tested in different groups. The scale can be applied to individuals over the age of 14. The State/Trait Anxiety Scale includes 40 statements that individuals can use to express their feelings. Depending on how the individual feels and the severity of his/her emotions, it is possible to rate them as "Not at all" (1), "A little" (2), "Quite a bit" (3), "Completely" (4) should mark one of the options.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2023
Last Updated
April 25, 2023
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT05831514
Brief Title
Developing a Mobile Application for the Care of Children With Gastrostomy and The Effect of the Application on Gastrostomy
Official Title
Developing a Mobile Application for the Care of Children With Gastrostomy and The Effect of the Application on Gastrostomy Complications, Parental Care Burden, Self-Efficacy, and Anxiety Levels
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 28, 2023 (Anticipated)
Primary Completion Date
June 28, 2024 (Anticipated)
Study Completion Date
August 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Parents of children with gastrostomy have problems with the selection and preparation of nutritional products and catheter care during home care. Parents express that they want to receive practical training in the process of home care of the child with gastrostomy, they want to communicate more with the team and they need continuous monitoring to solve the problems encountered effectively. In this context, it is aimed to establish an appropriate training programme for the care of children with gastrostomy, to provide counselling and follow-up. Digital health technologies are divided into different sub-branches. Mobile health applications constitute one of these structures. Mobile health applications are used in elective surgical interventions in pediatric surgery (tonsillectomy, hernia repair, circumcision, etc.) and in the home care process after organ transplantation. In pediatric surgery, many mobile health applications have been developed to support pain management, symptom monitoring, medication adherence, support care processes, postoperative follow-up and self-management processes. In mobile health applications, no mobile application has been found for the use of parents of children with gastrostomy. In Turkey, there is no known nursing study for the use of parents of children with gastrostomy. The aim of this study is to develop a mobile application for the care of children with gastrostomy and to determine the effect of the application on gastrostomy complications, care burden of parents, self-efficacy and anxiety level.
Detailed Description
Parents of children with gastrostomy have problems with the selection and preparation of nutritional products and catheter care during home care. Parents express that they want to receive practical training in the process of home care of the child with gastrostomy, they want to communicate more with the team and they need continuous monitoring to solve the problems encountered effectively. In this context, it is aimed to establish an appropriate training programme for the care of children with gastrostomy, to provide counselling and follow-up. Digital health technologies are divided into different sub-branches. Mobile health applications constitute one of these structures. Mobile health applications are used in elective surgical interventions in pediatric surgery (tonsillectomy, hernia repair, circumcision, etc.) and in the home care process after organ transplantation. In pediatric surgery, many mobile health applications have been developed to support pain management, symptom monitoring, medication adherence, support care processes, postoperative follow-up and self-management processes. In mobile health applications, no mobile application has been found for the use of parents of children with gastrostomy. In Turkey, there is no known nursing study for the use of parents of children with gastrostomy. The aim of this study is to develop a mobile application for the care of children with gastrostomy and to determine the effect of the application on gastrostomy complications, care burden of parents, self-efficacy and anxiety level. This research was planned in two stages as follows: In the first stage, it was aimed to develop a mobile application supported education programme (G-MUEP) for the care of children with gastrostomy. In the second stage, it was aimed to evaluate the effectiveness of G-MUEP. For this purpose, the hypotheses of the research are as follows: Parents using G-MUEP are more effective than the parents in the control group; Hypothesis 1 (H1): care burden is less. Hypothesis 2 (H1): their self-efficacy is higher. Hypothesis 3 (H1): anxiety levels are lower. Compared to the children in the control group, the children of the parents using G-MUEP; Hypothesis 1 (H1): gastrostomy-related complication findings are less.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Diseases, Gastrointestinal Diseases
Keywords
Care burden, Parent education, Gastrostomy, Nursing, M-health application, Self-efficacy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The research type is a pre-test-repeated post-test randomized controlled single blind study.
Masking
Participant
Masking Description
In the study, it will be ensured that the parents participating in the research do not know which group they are in. Therefore, one-way blinding will be applied in the study.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Parents who meet the inclusion criteria will be informed about the study and invited to participate in the study. Verbal and written consent will be obtained from parents who meet the inclusion criteria and agree to participate in the study. In the pretest, the Complications Checklist, Zarit Caregiver Burden Scale, General Self-Efficacy Scale, State/Trait Anxiety Scale are completed by the parents. The mobile application will be introduced to the parents and they will be allowed to download it to their phones. Parents will be ensured to actively use the mobile application for three months. At the first month follow-up, the Complications Checklist, Zarit Caregiver Burden Scale, General Self-Efficacy Scale, State/Trait Anxiety Scale are completed by the parents. In the post-test, the Complications Checklist, Zarit Caregiver Burden Scale, General Self-Efficacy Scale, State/Trait Anxiety Scale are completed by the parents.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Parents who meet the inclusion criteria will be informed about the study and invited to participate in the study. Verbal and written consent will be obtained from parents who meet the inclusion criteria and agree to participate in the study. In the pretest, the Complications Checklist, Zarit Caregiver Burden Scale, General Self-Efficacy Scale, State/Trait Anxiety Scale are completed by the parents. At the first month follow-up, the Complications Checklist, Zarit Caregiver Burden Scale, General Self-Efficacy Scale, State/Trait Anxiety Scale are completed by the parents. In the post-test, the Complications Checklist, Zarit Caregiver Burden Scale, General Self-Efficacy Scale, State/Trait Anxiety Scale are completed by the parents.
Intervention Type
Other
Intervention Name(s)
Mobile Application Supported Education Program (G-MUEP)
Intervention Description
Parents who meet the inclusion criteria will use the Mobile Application Supported Education Program (G-MUEP).
Primary Outcome Measure Information:
Title
Complication Checklist
Description
A complication checklist consisting of 14 items was created by the researcher to determine the gastrostomy-related complications of the child with gastrostomy by reviewing the relevant literature.
Time Frame
3 Months
Title
Zarit Caregiver Burden Scale
Description
Zarit Caregiver Burden Scale was developed by Zarit, Reever and Bach Peterson in 1980. It is used to assess the distress experienced by caregivers of individuals in need of care. The scale is a Likert-type scale ranging from 1 to 5 as 'never', 'rarely', 'sometimes', 'often' or 'almost always'. Özlü, Yıldız & Aker (2009), who adapted the scale into Turkish, found the Cronbach's alpha coefficient of the scale to be 0.83 (Özlü, Yıldız, & Aker, 2009). A minimum score of zero and a maximum score of 76 can be obtained from the scale. The items in the scale are generally related to the social and emotional domain, and a high scale score indicates that the distress experienced is high.
Time Frame
3 Months
Title
General Self-Efficacy Scale
Description
The General Self-Efficacy Scale, developed by Schwarzer and Jarusalem in 1995 and validated by Aypay (2010) in Turkish, consists of 10 items in total. The scale, whose response category consists of a 4-point scale, is scored as "Completely wrong = 1 point", "Somewhat correct = 2 points", "Moderately correct = 3 points", and "Completely correct = 4 points". There are no reverse items and no cut-off points in the scale. The minimum score is 10 and the maximum score is 40. As the scale score increases, perceived self-efficacy increases. The Cronbach's alpha coefficient calculated in the Turkish validity-reliability study was found to be 0.83.
Time Frame
3 Months
Title
State/Trait Anxiety Scale
Description
State-Trait Anxiety Inventory will be used to measure the anxiety level of the parents. The State-Trait Anxiety Inventory was developed by Spielberger et al. (1970), translated into Turkish by Necla Öner and Le Compte in 1985, and its validity and reliability were tested in different groups. The scale can be applied to individuals over the age of 14. The State/Trait Anxiety Scale includes 40 statements that individuals can use to express their feelings. Depending on how the individual feels and the severity of his/her emotions, it is possible to rate them as "Not at all" (1), "A little" (2), "Quite a bit" (3), "Completely" (4) should mark one of the options.
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The gastrostomy was opened for the child within the last six months, The parent's willingness to participate in the study, The parent is literate in Turkish, Parental use of mobile devices, The parent has internet access, The parent has no communication barriers. Exclusion Criteria: -The parent has internet access problems.
Facility Information:
Facility Name
Turkey
City
Antalya
ZIP/Postal Code
07070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.
Citations:
PubMed Identifier
33047836
Citation
Suluhan D, Yildiz D, Surer I, Fidanci Eren B, Balamtekin N. Effect of Gastrostomy Tube Feeding Education on Parents of Children with Gastrostomy. Nutr Clin Pract. 2021 Dec;36(6):1220-1229. doi: 10.1002/ncp.10586. Epub 2020 Oct 13.
Results Reference
background
PubMed Identifier
29219857
Citation
Pars H, Cavusoglu H. A Literature Review of Percutaneous Endoscopic Gastrostomy: Dealing With Complications. Gastroenterol Nurs. 2019 Jul/Aug;42(4):351-359. doi: 10.1097/SGA.0000000000000320.
Results Reference
background
PubMed Identifier
34269704
Citation
Kahveci G, Akin S. Knowledge Levels and Practices About the Enteral Nutritional Practices of Informal Caregivers Caring for Patients Fed Through a Percutaneous Endoscopic Gastrostomy Tube: A Descriptive Observational Study. Gastroenterol Nurs. 2021 Sep-Oct 01;44(5):E80-E90. doi: 10.1097/SGA.0000000000000623.
Results Reference
background
PubMed Identifier
29194216
Citation
Fuchs S. Gastrostomy Tubes: Care and Feeding. Pediatr Emerg Care. 2017 Dec;33(12):787-791. doi: 10.1097/PEC.0000000000001332.
Results Reference
background
PubMed Identifier
35007816
Citation
Bischoff SC, Austin P, Boeykens K, Chourdakis M, Cuerda C, Jonkers-Schuitema C, Lichota M, Nyulasi I, Schneider SM, Stanga Z, Pironi L. ESPEN practical guideline: Home enteral nutrition. Clin Nutr. 2022 Feb;41(2):468-488. doi: 10.1016/j.clnu.2021.10.018. Epub 2021 Nov 24.
Results Reference
background
PubMed Identifier
25024606
Citation
Blumenstein I, Shastri YM, Stein J. Gastroenteric tube feeding: techniques, problems and solutions. World J Gastroenterol. 2014 Jul 14;20(26):8505-24. doi: 10.3748/wjg.v20.i26.8505.
Results Reference
background
PubMed Identifier
31519400
Citation
Choi EK, Jung E, Ji Y, Bae E. A 2-Step Integrative Education Program and mHealth for Self-Management in Korean Children with Spina Bifida: Feasibility Study. J Pediatr Nurs. 2019 Nov-Dec;49:e54-e62. doi: 10.1016/j.pedn.2019.09.002. Epub 2019 Sep 10.
Results Reference
background
PubMed Identifier
31755137
Citation
Pars H, Soyer T. Home Gastrostomy Feeding Education Program: Effects on the Caregiving Burden, Knowledge, and Anxiety Level of Mothers. JPEN J Parenter Enteral Nutr. 2020 Aug;44(6):1029-1037. doi: 10.1002/jpen.1747. Epub 2019 Nov 21.
Results Reference
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Developing a Mobile Application for the Care of Children With Gastrostomy and The Effect of the Application on Gastrostomy

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