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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Pakistan

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:

  1. 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.
  2. 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
  3. 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.
  4. 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

  1. Name
  2. Gender
  3. Age (months )
  4. Ethnicity
  5. Weight (lbs)
  6. Height (cm)
  7. Percentile (Weight for age )
  8. Z score (weight for age )
  9. Phone No:
  10. Address
  11. Education level of mother father
  12. Smart phone knowledge (low/medium/high)
  13. Monthly income
  14. No of siblings
  15. No. of family members
  16. No of smart phones at home
  17. Diagnosis
  18. Primary surgery
  19. RACH score (class 1/class 2)
  20. CVA yes/no
  21. Creatinine ________
  22. Hb ________
  23. Albumin level _______
  24. Number of days in hospital
  25. Number of days in ICU
  26. Ventilator time
  27. Reopened yes/ no
  28. Food allergy Wheat ________ Milk __________ Nuts __________ Eggs___________ Other ___________
  29. Anorexia yes/ no
  30. Muscle dystrophy yes/ no
  31. Calories required
  32. Proteins required
  33. Carbohydrates required
  34. Fats required
  35. All vitamins will be listed (required)
  36. All minerals will be listed (required)
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 groups in NCT04782635
Study groupRoleWhat they receive
AI groupExperimental* 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 groupOther* 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.

  1. Weight changes

    observe the Weight changes , weight for age , Z score weight for age in both groups

    Measured: 2 months

  2. Caloric intake

    Check the average calories intake consumed in both groups

    Measured: 2 months

  3. Proteins intake

    Check the average proteins consumed in both groups

    Measured: 2 months

  4. 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

  5. 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)
  1. carbohydrates intake

    Measure average carbohydrates consumed in both groups (intervention and usual care group) in mg

    Measured: 2 months

  2. fats intake

    Measure average fats consumed in both groups (intervention and usual care group) in mg

    Measured: 2 months

  3. Vitamins intake

    Measure average vitamins consumed in both groups (intervention and usual care group) in mg and µg

    Measured: 2 months

  4. 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.

  1. First posted4 Mar 2021
  2. Study start25 Mar 2021
  3. Primary completion1 Aug 2021
  4. Study completion3 Aug 2021

Resources

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)
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 38618548
  • Zahid 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

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.

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