Post-cardiac SurgeryNCT04782635
Effect of Artificial Intelligence on Nutritional Status of Children Post Cardiac Surgery
A study testing mobile based application and Pamphlet in people with Post-cardiac Surgery, run by Al-Shifa Trust Eye Hospital at 2 sites in Pakistan.
Trial summary
The objective of the study will be to assess the effect of artificial intelligence on nutritional status of children post cardiac surgery in comparison to usual care group.To assess usefulness of diet related mobile application in comparison to usual care group.To identify diet related problems among children post… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Post-cardiac Surgery
- What is being tested?
- mobile based application and Pamphlet
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesPakistan
- Study dates
- 25 Mar 2021to 3 Aug 2021
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of age 2-12 (early and middle childhood) years will be included in the study.
- Surgeries within first and second class of RACHS score are included in the study.
- Patients with smart phones and internet facilities are included in the study.
- Patients with caregivers who can read English are included in the study
- Patients discharged from the hospital will be selected
Who cannot join
- Patients with multiple congenital abnormalities and surgeries without an RACHS score are excluded.
- Patient who will be rehospitalized will be excluded from the research
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Armed Forces Institute of Cardiology and National Institute of Heart Disease
Rawalpindi, Punjab Province, 46000
Maryam Zahid
Rawalpindi, Punjab Province
About this study
The objective of the study will be to assess the effect of artificial intelligence on nutritional status of children post cardiac surgery in comparison to usual care group.To assess usefulness of diet related mobile application in comparison to usual care group.To identify diet related problems among children post cardiac surgery in both groups (usual care group and intervention group ).
Read the detailed description
Research question Is there any impact of artificial intelligence on nutritional status of children post cardiac surgery?
Null hypothesis:
There is no impact of artificial intelligence on nutritional status of children post cardiac surgery
Operational definition:
- Cardiac surgery There are large number of different surgical procedures (more than 150) in congenital heart disease, it became necessary the grouping into categories or relatively homogeneous strata, so that the comparisons between the outcomes were performed. The RACHS-1 method was developed by the Children's Hospital Boston team through a panel of 11 nationally representative members of pediatric cardiologists and cardiac surgeon. It allocated 207 surgical procedures in 6 different categories with similar risk for hospital mortality.
- Artificial intelligence (AI) Artificial intelligence is a way to make machines think and behave intelligently. These machines are controlled by software inside them, so AI has a lot to do with intelligent software programs that can control these machines. It is a science that can help machines understand the world and accordingly react to situations in the same way the humans do.27
- Nutritional status The state of a person's health in terms of the nutrients in his or her diet. Nutritional status assessment is the interpretation of anthropometric (using Length-for-age and Weight-for-age clinical growth charts and Z score), clinical (muscle dystrophy) and dietary data (food frequency table, usual dietary intake and mobile based application) to determine whether a person or groups of people are well nourished or malnourished.
- Nutrition related mobile application Application basic function would be support and improve nutrition status of children. Personalization of goals and challenges, daily intake of calories, carbohydrates, proteins, fats, minerals and vitamins will be tracked, food logging, food tracking, meal and supplement reminders, recipes, visual cues (remaining calories) will be notified, episodes of vomiting, meals missed, diarrhea, nausea will be recorded , meal planned according to the food preferences of child, food composition table, nutrition blogs and articles
Material and Methods:
STUDY DESIGN:
Randomized controlled trial
SETTING:
Tertiary Care Cardiac hospital, Rawalpindi , Pakistan.
SAMPLING TECNIQUE:
Permuted block BLINDING Double blinded study
SAMPLE SIZE:
Sample size is estimated to be 96, 48 in each group i.e. intervention and control group
DATA ANALYSIS PROCEDURE All data will be analyzed using SPSS 23 Descriptive statistics
- Percentages and frequencies for all categorical variables
- Categorical Data will be presented in form of bar and chart
- Mean and standard deviation for continuous data. Inferential statistics
- For comparison of characteristics of patients between usual care group and intervention group:
- Independent t-test for continuous variables
- Chi square for categorical variables
- Pre-test and post-test difference in mean changes will be assessed by Split-plot ANOVA
- To compare outcomes between usual care group and intervention group Chi square group will be used
Ethical consideration The study will start after presenting research proposal and obtaining ethical approval from Ethical Review Committee of Pakistan Institute of Ophthalmology, Al-Shifa School of Public Health. A formal letter will be used that will include the information relevant to the study e.g., the purpose and duration of this study, the level of privacy and confidentiality of information with anonymity of the respondents. While conducting this study, informed consent from all participants will be taken verbally and in written form. Participation will be voluntary and individuals will be informed that they can withdraw at any time and that all data will be treated confidentially. Subjects will be assured of anonymity and confidentiality. Patients will be given a broad outline of the research, an indication of the type of information that is required, the reasons why the research is being carried out and how the information which they provided will be used.
Independent variable
- Name
- Gender
- Age (months )
- Ethnicity
- Weight (lbs)
- Height (cm)
- Percentile (Weight for age )
- Z score (weight for age )
- Phone No:
- Address
- Education level of mother father
- Smart phone knowledge (low/medium/high)
- Monthly income
- No of siblings
- No. of family members
- No of smart phones at home
- Diagnosis
- Primary surgery
- RACH score (class 1/class 2)
- CVA yes/no
- Creatinine ________
- Hb ________
- Albumin level _______
- Number of days in hospital
- Number of days in ICU
- Ventilator time
- Reopened yes/ no
- Food allergy Wheat ________ Milk __________ Nuts __________ Eggs___________ Other ___________
- Anorexia yes/ no
- Muscle dystrophy yes/ no
- Calories required
- Proteins required
- Carbohydrates required
- Fats required
- All vitamins will be listed (required)
- All minerals will be listed (required)
- Conditions
- Post-cardiac Surgery
- Being tested
- mobile based application, Pamphlet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile based applicationDevice
Application basic function would be support and improve nutrition status of children. Personalization of goals and challenges, daily intake of calories, carbohydrates, proteins, fats, minerals and vitamins will be tracked, food logging, food tracking, meal and supplement reminders, recipes, visual cues (remaining calories) will be notified, episodes of vomiting, meals missed, diarrhea, nausea will be recorded , meal planned according to the food preferences of child, food composition table, nutrition blogs and articles
PamphletBehavioural
A pamphlet which will be provide knowledge to the patients
| Study group | Role | What they receive |
|---|---|---|
| AI group | Experimental | * Care givers will be selected through permuted block.
* They will be explained the procedure of intervention and written consent will be asked.
* Mobile application will be installed in their mobile.
* They will be explained the working of mobile application
* Application will make a standard diet plan for the child according to the requirements of the child
* Then the child will use the application for one month.
* After one month patient will visit the doctor for routine checkup, during the visit patient will be asked for the usefulness of the application.
* Nutritional status of the patient will be monitored including weight, height, clinical signs, dietary history and will be updated in application.
* Then patient will follow the application for one month
* After another one month patient will visit the doctor for routine checkup, during the visit patient will be asked for the usefulness of the application and nutritional status will be measured Receives: Device: mobile based application |
| usual care group | Other | * Caregivers (Mothers/fathers/guardians) will be selected through permuted block.
* Patient weight, height, clinical signs will be noted.
* Caregivers will be handed over pamphlet regarding dietary instructions on discharge.
* After one month patient will visit the doctor for routine checkup, during the visit nutritional status of the patient will be checked and noted including weight, height, clinical signs and dietary history.
* Patient will leave hospital with no added dietary instruction.
* After one month patient will visit the doctor for routine checkup, during the visit nutritional status of the patient will be checked and noted weight, height, clinical sign, and dietary history. Receives: Behavioral: Pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight changes
observe the Weight changes , weight for age , Z score weight for age in both groups
Measured: 2 months
Caloric intake
Check the average calories intake consumed in both groups
Measured: 2 months
Proteins intake
Check the average proteins consumed in both groups
Measured: 2 months
Mobile application usage
Patients will be asked whether the language used in application on a likert scale ranging from very easy to very difficult , handling application will be ranging from very easy to very difficult, cost effectiveness will be ranging from yes to very costly, Visual cues in application will be ranged from useful to difficult to understand, Recipes in application will be ranged from being Useful to not useful, Meal reminders will be ranged from being useful to irritating
Measured: 2 months
nutritional issues
Patient will be inquired regarding the episodes of vomiting, diarrhea, loss of appetite and other nutritional related problems
Measured: 2 months
Secondary outcomes (4)
carbohydrates intake
Measure average carbohydrates consumed in both groups (intervention and usual care group) in mg
Measured: 2 months
fats intake
Measure average fats consumed in both groups (intervention and usual care group) in mg
Measured: 2 months
Vitamins intake
Measure average vitamins consumed in both groups (intervention and usual care group) in mg and µg
Measured: 2 months
Minerals intake
Measure average minerals consumed in both groups (intervention and usual care group) in mg and µg
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start25 Mar 2021
- Primary completion1 Aug 2021
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-cardiac SurgeryStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Shifa Trust Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Zahid, Al-Shifa Trust Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782635
- Sponsor's protocol ID
- AlShifaTrustEye
- Status last verified
- Aug 2021
- First submitted
- 24 Feb 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
Zahid M, Sughra U, Mumtaz S, Hassan M. Improving nutritional status of children using artificial intelligence-based mobile application postsurgery: randomised controlled trial. BMJ Nutr Prev Health. 2023 Dec 2;6(2):367-373. doi: 10.1136/bmjnph-2023-000645. eCollection 2023.
PubMed 38618548Zahid M, Sughra U. Development of a protocol for conducting a randomized control trial on effects of artificial intelligence on nutritional status of children post cardiac surgery. J Pak Med Assoc. 2022 May;72(5):908-911. doi: 10.47391/JPMA.3751.
PubMed 35713054
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Artificial Intelligence on Nutritional Status of Children Post Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04782635
- Acronym / sponsor ID
- AlShifaTrustEye
- Conditions
- Post-cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Al-Shifa Trust Eye HospitalUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 4 Mar 2021 (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 objective of the study will be to assess the effect of artificial intelligence on nutritional status of children post cardiac surgery in comparison to usual care group.To assess usefulness of diet related mobile application in comparison to usual care group.To identify diet related problems among children post cardiac surgery in both groups (usual care group and intervention group ).
Detailed description
Research question Is there any impact of artificial intelligence on nutritional status of children post cardiac surgery?
Null hypothesis:
There is no impact of artificial intelligence on nutritional status of children post cardiac surgery
Operational definition:
- Cardiac surgery There are large number of different surgical procedures (more than 150) in congenital heart disease, it became necessary the grouping into categories or relatively homogeneous strata, so that the comparisons between the outcomes were performed. The RACHS-1 method was developed by the Children's Hospital Boston team through a panel of 11 nationally representative members of pediatric cardiologists and cardiac surgeon. It allocated 207 surgical procedures in 6 different categories with similar risk for hospital mortality.
- Artificial intelligence (AI) Artificial intelligence is a way to make machines think and behave intelligently. These machines are controlled by software inside them, so AI has a lot to do with intelligent software programs that can control these machines. It is a science that can help machines understand the world and accordingly react to situations in the same way the humans do.27
- Nutritional status The state of a person's health in terms of the nutrients in his or her diet. Nutritional status assessment is the interpretation of anthropometric (using Length-for-age and Weight-for-age clinical growth charts and Z score), clinical (muscle dystrophy) and dietary data (food frequency table, usual dietary intake and mobile based application) to determine whether a person or groups of people are well nourished or malnourished.
- Nutrition related mobile application Application basic function would be support and improve nutrition status of children. Personalization of goals and challenges, daily intake of calories, carbohydrates, proteins, fats, minerals and vitamins will be tracked, food logging, food tracking, meal and supplement reminders, recipes, visual cues (remaining calories) will be notified, episodes of vomiting, meals missed, diarrhea, nausea will be recorded , meal planned according to the food preferences of child, food composition table, nutrition blogs and articles
Material and Methods:
STUDY DESIGN:
Randomized controlled trial
SETTING:
Tertiary Care Cardiac hospital, Rawalpindi , Pakistan.
SAMPLING TECNIQUE:
Permuted block BLINDING Double blinded study
SAMPLE SIZE:
Sample size is estimated to be 96, 48 in each group i.e. intervention and control group
DATA ANALYSIS PROCEDURE All data will be analyzed using SPSS 23 Descriptive statistics
- Percentages and frequencies for all categorical variables
- Categorical Data will be presented in form of bar and chart
- Mean and standard deviation for continuous data. Inferential statistics
- For comparison of characteristics of patients between usual care group and intervention group:
- Independent t-test for continuous variables
- Chi square for categorical variables
- Pre-test and post-test difference in mean changes will be assessed by Split-plot ANOVA
- To compare outcomes between usual care group and intervention group Chi square group will be used
Ethical consideration The study will start after presenting research proposal and obtaining ethical approval from Ethical Review Committee of Pakistan Institute of Ophthalmology, Al-Shifa School of Public Health. A formal letter will be used that will include the information relevant to the study e.g., the purpose and duration of this study, the level of privacy and confidentiality of information with anonymity of the respondents. While conducting this study, informed consent from all participants will be taken verbally and in written form. Participation will be voluntary and individuals will be informed that they can withdraw at any time and that all data will be treated confidentially. Subjects will be assured of anonymity and confidentiality. Patients will be given a broad outline of the research, an indication of the type of information that is required, the reasons why the research is being carried out and how the information which they provided will be used.
Independent variable
- Name
- Gender
- Age (months )
- Ethnicity
- Weight (lbs)
- Height (cm)
- Percentile (Weight for age )
- Z score (weight for age )
- Phone No:
- Address
- Education level of mother father
- Smart phone knowledge (low/medium/high)
- Monthly income
- No of siblings
- No. of family members
- No of smart phones at home
- Diagnosis
- Primary surgery
- RACH score (class 1/class 2)
- CVA yes/no
- Creatinine ________
- Hb ________
- Albumin level _______
- Number of days in hospital
- Number of days in ICU
- Ventilator time
- Reopened yes/ no
- Food allergy Wheat ________ Milk __________ Nuts __________ Eggs___________ Other ___________
- Anorexia yes/ no
- Muscle dystrophy yes/ no
- Calories required
- Proteins required
- Carbohydrates required
- Fats required
- All vitamins will be listed (required)
- All minerals will be listed (required)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI group | Experimental | Device: mobile based application* Care givers will be selected through permuted block. * They will be explained the procedure of intervention and written consent will be asked. * Mobile application will be installed in their mobile. * They will be explained the working of mobile application * Application will make a standard diet plan for the child according to the requirements of the child * Then the child will use the application for one month. * After one month patient will visit the doctor for routine checkup, during the visit patient will be asked for the usefulness of the application. * Nutritional status of the patient will be monitored including weight, height, clinical signs, dietary history and will be updated in application. * Then patient will follow the application for one month * After another one month patient will visit the doctor for routine checkup, during the visit patient will be asked for the usefulness of the application and nutritional status will be measured |
| usual care group | Other | Behavioral: Pamphlet* Caregivers (Mothers/fathers/guardians) will be selected through permuted block. * Patient weight, height, clinical signs will be noted. * Caregivers will be handed over pamphlet regarding dietary instructions on discharge. * After one month patient will visit the doctor for routine checkup, during the visit nutritional status of the patient will be checked and noted including weight, height, clinical signs and dietary history. * Patient will leave hospital with no added dietary instruction. * After one month patient will visit the doctor for routine checkup, during the visit nutritional status of the patient will be checked and noted weight, height, clinical sign, and dietary history. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children of age 2-12 (early and middle childhood) years will be included in the study.
- Surgeries within first and second class of RACHS score are included in the study.
- Patients with smart phones and internet facilities are included in the study.
- Patients with caregivers who can read English are included in the study
- Patients discharged from the hospital will be selected
Key exclusion criteria (2 listed)
- Patients with multiple congenital abnormalities and surgeries without an RACHS score are excluded.
- Patient who will be rehospitalized will be excluded from the research
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 based applicationApplication basic function would be support and improve nutrition status of children. Personalization of goals and challenges, daily intake of calories, carbohydrates, proteins, fats, minerals and vitamins will be tracked, food logging, food tracking, meal and supplement reminders, recipes, visual cues (remaining calories) will be notified, episodes of vomiting, meals missed, diarrhea, nausea will be recorded , meal planned according to the food preferences of child, food composition table, nutrition blogs and articles | Device | AI group |
| PamphletA pamphlet which will be provide knowledge to the patients | Behavioural | usual care group |
Primary outcome
Weight changes
Time frame: 2 months
observe the Weight changes , weight for age , Z score weight for age in both groups
Caloric intake
Time frame: 2 months
Check the average calories intake consumed in both groups
Proteins intake
Time frame: 2 months
Check the average proteins consumed in both groups
Mobile application usage
Time frame: 2 months
Patients will be asked whether the language used in application on a likert scale ranging from very easy to very difficult , handling application will be ranging from very easy to very difficult, cost effectiveness will be ranging from yes to very costly, Visual cues in application will be ranged from useful to difficult to understand, Recipes in application will be ranged from being Useful to not useful, Meal reminders will be ranged from being useful to irritating
nutritional issues
Time frame: 2 months
Patient will be inquired regarding the episodes of vomiting, diarrhea, loss of appetite and other nutritional related problems
4 secondary outcomes
carbohydrates intake
Time frame: 2 months
fats intake
Time frame: 2 months
Vitamins intake
Time frame: 2 months
Minerals intake
Time frame: 2 months
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 4 Aug 2021.
- Derived from this study: PubMed 38618548Zahid M, Sughra U, Mumtaz S, Hassan M. Improving nutritional status of children using artificial intelligence-based mobile application postsurgery: randomised controlled trial. BMJ Nutr Prev Health. 2023 Dec 2;6(2):367-373. doi: 10.1136/bmjnph-2023-000645. eCollection 2023.
- Derived from this study: PubMed 35713054Zahid M, Sughra U. Development of a protocol for conducting a randomized control trial on effects of artificial intelligence on nutritional status of children post cardiac surgery. J Pak Med Assoc. 2022 May;72(5):908-911. doi: 10.47391/JPMA.3751.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile based application and Pamphlet in people with Post-cardiac Surgery, run by Al-Shifa Trust Eye Hospital at 2 sites in Pakistan.
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 5 inclusion and 2 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 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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?
Weight changes (time frame: 2 months). The study lists 5 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 NCT04782635, which also lists 2 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 4 Aug 2021.