Neuromuscular DiseasesNCT05831514
Developing a Mobile Application for the Care of Children With Gastrostomy and The Effect of the Application on Gastrostomy
A study testing Mobile Application Supported Education Program (G-MUEP) in people with Neuromuscular Diseases and Gastrointestinal Diseases, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Diseases, Gastrointestinal Diseases
- What is being tested?
- Mobile Application Supported Education Program (G-MUEP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jul 2023to 28 Aug 2024
- 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 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -The parent has internet access problems.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Neuromuscular Diseases, Gastrointestinal Diseases
- Being tested
- Mobile Application Supported Education Program (G-MUEP)
- Keywords
- Care burden, Parent education, Gastrostomy, Nursing, M-health application, Self-efficacy
- Medical subject headings
- Neuromuscular Diseases, Gastrointestinal Diseases, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Application Supported Education Program (G-MUEP)Other
Parents who meet the inclusion criteria will use the Mobile Application Supported Education Program (G-MUEP).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: Mobile Application Supported Education Program (G-MUEP) |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Months
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.
Measured: 3 Months
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.
Measured: 3 Months
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.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start28 Jul 2023 (estimated)
- Primary completion28 Jun 2024 (estimated)
- Study completion28 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- The research type is a pre-test-repeated post-test randomized controlled single blind study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yahya ERGEZEN, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831514
- Sponsor's protocol ID
- KoçVakfıBursu
- Other IDs
- 2023.6
- Status last verified
- Apr 2023
- First submitted
- 29 Mar 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
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.
PubMed 33047836Pars 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.
PubMed 29219857Kahveci 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.
PubMed 34269704Fuchs S. Gastrostomy Tubes: Care and Feeding. Pediatr Emerg Care. 2017 Dec;33(12):787-791. doi: 10.1097/PEC.0000000000001332.
PubMed 29194216Bischoff 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.
PubMed 35007816Blumenstein 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.
PubMed 25024606Choi 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.
PubMed 31519400Pars 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.
PubMed 31755137
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05831514
- Acronym / sponsor ID
- KoçVakfıBursu
- Conditions
- Neuromuscular Diseases, Gastrointestinal Diseases
- Keywords
- Care burden, Parent education, Gastrostomy, Nursing, M-health application, Self-efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 28 Jul 2023 (estimated)
- Primary completion
- 28 Jun 2024 (estimated)
- Study completion
- 28 Aug 2024 (estimated)
- First posted
- 26 Apr 2023 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The research type is a pre-test-repeated post-test randomized controlled single blind study.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Mobile Application Supported Education Program (G-MUEP)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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (1 listed)
- -The parent has internet access problems.
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 |
|---|---|---|
| Mobile Application Supported Education Program (G-MUEP)Parents who meet the inclusion criteria will use the Mobile Application Supported Education Program (G-MUEP). | Other | Intervention Group |
Primary outcome
Complication Checklist
Time frame: 3 Months
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
Time frame: 3 Months
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
Time frame: 3 Months
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
Time frame: 3 Months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Background: PubMed 33047836Suluhan 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.
- Background: PubMed 29219857Pars 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.
- Background: PubMed 34269704Kahveci 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.
- Background: PubMed 29194216Fuchs S. Gastrostomy Tubes: Care and Feeding. Pediatr Emerg Care. 2017 Dec;33(12):787-791. doi: 10.1097/PEC.0000000000001332.
- Background: PubMed 35007816Bischoff 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.
- Background: PubMed 25024606Blumenstein 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.
- Background: PubMed 31519400Choi 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.
- Background: PubMed 31755137Pars 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.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application Supported Education Program (G-MUEP) in people with Neuromuscular Diseases and Gastrointestinal Diseases, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Apr 2023. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Complication Checklist (time frame: 3 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05831514, which also lists 8 linked publications.
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 26 Apr 2023.