CTRI Number	CTRI/2020/11/029443 [Registered on: 27/11/2020] Trial Registered Prospectively
Last Modified On:	12/03/2021
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Other (Specify) [Complex Healthcare Intervention]
Study Design	Single Arm Study
Public Title of Study	AIIMS ICU Rehabilitation Project
Scientific Title of Study Modification(s)	Home-Based Rehabilitation for chronically ill ICU patients- AIR project
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Swagata Tripathy  Address  Room 406, Academic Block, AIIMS, Bhubaneswar. Sijua, Patrapada Khordha ORISSA 751019 India  Phone  08763400534   Fax     Email  tripathyswagata@gmail.com
Details Contact Person Scientific Query Modification(s)	Name  Swagata Tripathy  Address  Room 406, Academic Block, AIIMS, Bhubaneswar. Sijua, Patrapada Khordha ORISSA 751019 India  Phone  08763400534   Fax     Email  tripathyswagata@gmail.com
Details Contact Person Public Query Modification(s)	Name  Swagata Tripathy  Address  Room 406, Academic Block, AIIMS, Bhubaneswar. Sijua, Patrapada Khordha ORISSA 751019 India  Phone  08763400534   Fax     Email  tripathyswagata@gmail.com
Source of Monetary or Material Support Modification(s)	National Health Mission, Annex Building, SIHFW, Bira Maharana Ln, Nilakantha Nagar, Nayapalli, Bhubaneswar, Odisha 751012
Primary Sponsor Modification(s)	Name  Swagata Tripathy  Address  Room 406, Academic Block Sijua, Patrapada, AIIMS Bhubaneswar  Type of Sponsor  Other []
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Swagata Tripathy  AIIMS Bhubaneswar  Room 406, Academic Block,Sijua, Patrapada Khordha   08763400534 tripathyswagata@gmal.com
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  AIIMS Bhubaneswar  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Illness, unspecified
Intervention / Comparator Agent	Type  Name  Details  Intervention  Development, Piloting, Evaluation, and Implementation of a Complex Intervention to support iHome Based Rehabilitation Project for Chronically Ill ICU patients  The complex intervention is proposed to have 3 limbs- Training & Nutrition/ Mobile app/ Equipment bank  Comparator Agent  This will be in the phase of final evaluation of the complex intervention, after field testing.  The group of patients who refuse the intervention or adopt certain limited limbs of the intervention will form the comparator arm
Inclusion Criteria	Age From  16.00 Year(s) Age To  99.99 Year(s) Gender  Both  Details  Chronically ill, tracheostomised ICU patients Family or caregiver motivated to accept the complex healthcare intervention
ExclusionCriteria	Details  Hemodynamically unstable, Braindead or family not motivated to accept the intervention
Method of Generating Random Sequence	Not Applicable
Method of Concealment	Not Applicable
Blinding/Masking	Open Label
Primary Outcome Modification(s)	Outcome  TimePoints  Feasibility and acceptibility of designing, testing and implementing a complex healthcare intevention for the chronically ill, ICU patient  Daily in-hospital and weekly after rehabilitation for first 1 month and second weekly or as needed thereafter
Secondary Outcome Modification(s)	Outcome  TimePoints  Field testing and evaluation of the complex intervention  weekly. Post development stage as per MRC guidelines for development of complex healthcare intervention
Target Sample Size	Total Sample Size="50" Sample Size from India="50"
Phase of Trial	Phase 2/ Phase 3
Date of First Enrollment (India)	01/12/2020
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="2" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details Modification(s)	NIL
Brief Summary	Research protocol for Development, Piloting, Evaluation, and Implementation of a Complex Intervention to support Home Based Rehabilitation Project for Chronically Ill ICU patients- AIIMS ICU Rehabilitation Project  - AIR. Overall aims of the research program 1. To understand from different perspectives, the range of supportive care needs for people with chronic critical illness requiring tracheostomy (Tracheostomised ICU Patient for rehab- TIPr) and the impact that these impairments have on outcomes such as quality of life and caregiver burden.  2. To design, pilot, field test, and evaluate a complex rehabilitative support care intervention - theoretically informed, test ready for a follow-up with a full scale definitive randomized controlled trial (RCT), if the field test of the development program appears favorable. 3. To evaluate the complex intervention with a full-scale RCT Primary specific objectives Stage 1: Mapping the gaps - To define the gaps in knowledge, understanding, availability, and hurdles in the support needs for chronic tracheostomized patients (TIPr) – by using inputs from the stakeholders- the patient, family stakeholders, and evidence from the literature. Stage 2: Developing a prototype complex intervention with preconceived arms (project protocol) as discussed with the funding agency, but refine the arms by examining the particular needs of the populace by utilizing a mixed-methods technique.  Stage 3: Refining the intervention further into a draft intervention prepared for field testing;  Stage 4: Field trial of the draft intervention The acceptability and feasibility of the prototype intervention will be tested. The most significant/ useful outcome measures that might be useful in the full trial –which will be taken as secondary specific objectives will be studied, assessed, and ascertained.