| CTRI Number |
CTRI/2019/10/021498 [Registered on: 01/10/2019] Trial Registered Prospectively |
| Last Modified On: |
24/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Mobile App for discharge teaching] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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“Use of Mobile App by nurses for discharge teaching of home-based care among postoperative neurosurgical patients or caregivers in a tertiary care hospital, New Delhi, India†|
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Scientific Title of Study
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“A study to assess the effectiveness of nurse driven mobile Application(App)based discharge teaching for home healthcare practices among postoperative neurosurgical patients or caregivers in a tertiary care hospital, New Delhi, India†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
METILDA CJ |
| Designation |
MSc Nursing Student |
| Affiliation |
AIIMS |
| Address |
College of nursing ,AIIMS
New Delhi
Ansari nagar ,New Delhi-110029
South
DELHI
110029
India |
| Phone |
9871236444 |
| Fax |
|
| Email |
metildajose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KAMLESH KUMARI SHARMA |
| Designation |
LECTURER |
| Affiliation |
AIIMS |
| Address |
College of nursing ,AIIMS
New delhi
Ansari nagar ,New Delhi-110029
South
DELHI
110029
India |
| Phone |
9811336985 |
| Fax |
|
| Email |
kamlesh_con@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
METILDA CJ |
| Designation |
MSc Nursing Student |
| Affiliation |
AIIMS |
| Address |
College of nursing ,AIIMS
New delhi
Ansari nagar ,New Delhi-110029
South
DELHI
110029
India |
| Phone |
9871236444 |
| Fax |
|
| Email |
metildajose@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [SELF] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| METILDA CJ |
AIIMS |
AIIMS,Dept of Neurosurgery ,NS3 Ward ,ANSARI NAGAR ,NEW DELHI-110029
South
DELHI |
9871236444
metildajose@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS ETHICS COMMITTE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional paper based Discharge summary(control) |
Paper based discharge summary will be given to the Control group |
| Intervention |
Mobile Application("AIMEO") for discharge advice |
Discharge teaching through Mobile App(interventional group) and paper based discharge advice(control group) |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. All adult postoperative neurosurgical patients discharged within 15 days after surgery
2. All adult neurosurgical patients who can read and write Hindi/English.
3. Patients having access to a smart Phone and who can use or understand how to use the app.
4. Age more than 18 years with or without neurological deficit. (Incase of neurological deficit in the patient ,caregiver can support the patient if he or she fulfils the above criteria no.2 and 3 )
5. Patients who are willing for the study.
|
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| ExclusionCriteria |
| Details |
1. All neurosurgical patients below 18yrs
2. All neurosurgical patients who cannot read and write Hindi/English
3. Not willing to participate in the study.
|
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of Mobile App-based discharge teaching module on home-based health care practices in terms of discharge advice compliance and satisfaction among neurosurgical patients/care givers. |
2 wks |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the usage of a smart phone among neurosurgical patients / caregivers. |
baseline |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 1 |
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Date of First Enrollment (India)
|
10/10/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Nil |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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Introduction:The neurological disorders can lead to severe disability and lifelong dependency in the life of a patient. The management of neurosurgical patients aims to reduce their disability and adapt themselves within society. In absence of formal rehabilitative facilities in India, patients have to depend on home-based support for rehabilitation & further management. There are considerable differences in the provision of home-based services in different communities for such patients. The inadequate home-based support can lead to further deterioration in the condition and financial burden in the families.The neurological disorders can lead to severe disability and lifelong dependency in the life of a patient. The management of neurosurgical patients aims to reduce their disability and adapt themselves within society. In absence of formal rehabilitative facilities in India, patients have to depend on home-based support for rehabilitation & further management. There are considerable differences in the provision of home-based services in different communities for such patients. The inadequate home-based support can lead to further deterioration in the condition and financial burden in the families.Most secondary impairments in neurosurgical patients can be significantly delayed or prevented by changes in their health behavior.It is very important to give paramount importance for a monitored home-based care which can result in improved quality of life in such patients. Non-adherence to medications can also result in serious implications for the patient’s overall health outcome, with incorrectly taken medications resulting in deterioration of the patient’s condition, drug resistance and potential accidental overdosing.hence this study is designed to assess and evaluate the efficiency of a mobile based App for discharge instructions ,compliance to medications through reminders and to study the role of nurse monitored patient engagement system which can reduce the physical follow-ups and increase the satisfaction among patients /care givers. Problem Statement: “A Randomized control study to assess the effectiveness of nurse driven discharge teaching using mobile application (App) for home-based healthcare practices among Post-operative neurosurgical patients or caregivers in a tertiary care hospital, New Delhi, India†Aims & Objectives:1.To assess the effectiveness nurse driven discharge teaching using mobile application (App) for home-based healthcare practices in terms of discharge advice compliance among Post-operative neurosurgical patients or caregivers. 2. To assess the effectiveness nurse driven discharge teaching using mobile application (App) for home-based healthcare practices in terms of satisfaction among Post-operative neurosurgical patients or caregivers. 3.To assess the usage of a smart phone among neurosurgical patients / caregivers Hypothesis(H1): The Mobile App based discharge teaching method will be effective for home-based healthcare practices of neurosurgery patients in terms of discharge advice compliance among neurosurgical patients . Hypothesis (H2): The Mobile App based discharge teaching method will be effective for home-based healthcare practices of neurosurgery patients in terms of Satisfaction among neurosurgical patients/caregivers Procedure for data collection: Study subjects >18 yrs will be screened for eligibility on the basis of Inclusion/ exclusion criteria. They will be allotted randomly to control and experimental group two from different wards of neurosurgery dept of two centers of AIIMS according to the inclusion criteria. Informed consent will be taken to be a part of the study.Control Group: The study subjects allotted to control group will be given the paper based conventional discharge summary advice by the concerned nurse and the subject data sheet will be collected from study subjects which includes demographic data, clinical data and screening sheet.The nurse investigator ensures that the homecare advices are received to the study subjects before the discharge. The control group will be given a self-structured questionnaire during the first routine follow-up visit within 30th day after discharge to assess the compliance to discharge advices, any complications and satisfaction among patients or caregivers. Interventional Group:Study subjects who fulfil the inclusion criteria will be randomly allotted to experimental group. They will be given training about the Mobile App and its functionalities during their admission so as to get confidence to use the App during their hospital stay. Each study subject will be given individual ID by the nurse investigator using the patients email ID. Daily 5-10 mts will be given to the study subjects for hand holding ie,using the Mobile App and resolving any queries. Once the patient is planned for discharge the nurse investigator will collect the data using subject data sheet which includes demographic, clinical profile and screening data. In addition to this, these patients will also receive routine discharge teaching from the concerned nurse or doctor using conventional paper-based discharge summery. Once the patient is aware about the discharge care to be done at home, the experimental group will be again adviced about the functionalities of the Mobile App. In case of neurological deficit in the patient, caregiver can support the patient if he or she can use or understand the functionalities to use a smart phone.The nurse investigator and doctors of Neurosurgery department at AIIMS New Delhi will be registered in the portal by creating secure online accounts in the “AIMEO†mobile App . Individualised discharge advice as per the discharge summary, for each patient will be entered in the App as templates for Home based care like (Medicine compliance Tracheostomy care, Foleys catheter care ,ryles tube care ,Back care, exercises and Diet ). Reminders will be sent in the form of push notifications or calls to the samples selected regarding their discharge advices.Through the app, patients will be prompted to maintain their medication compliance and health care practices. Feedback of completed tasks will be sent to the web portal as a dashboard where the nurse investigator and the doctors will have the access. Patients can send their queries and any images through the app securely to the web portal to the call center immediately after the discharge. The medical related queries will be sent to the nurse investigator and the nursing care related queries will be addressed by her and other queries will be escalated to the next level(concerned doctor). Patients will be also enrolled in a “whatsapp†group for focussed group discussion after taking their consen. A computerised log book will be maintained which include the date and time of the call, patient details ,type of queries, responses ,feedback ,call transferred to doctor etc. The effectiveness and satisfaction of mobile heath app and conventional discharge advices will be assessed by a self-structured questionnaire (Tool 2b) on the first routine followup visit /within 30th day .The data of the patient’s /caregivers usage of app to smart phone will also be analysed.
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