Clinical Trial Details (PDF Generation Date :- Sat, 25 Sep 2021 04:16:17 GMT)

PDF of Trial CTRI Website URL - http://ctri.nic.in

CTRI Number CTRI/2018/05/014041 [Registered on: 22/05/2018] - Trial Registered Retrospectively Last Modified On 16/05/2018 Post Graduate Thesis No Type of Trial Interventional Type of Study Preventive Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study Improving medical adherence in elderly with the use of an inteventional Tool-kit. Scientific Title of The Role Of An Educational Package In Improving Medication Adherence in Elderly Veterans Study Attending An Ex Servicemens Clinic:A Randomized Contolled Trial Secondary IDs if Any Secondary ID Identifier ICMR STS 2016-00250 NIL Details of Principal Details of Principal Investigator Investigator or overall Name Deepa Anne Thomas Trial Coordinator (multi-center study) Designation Doctor Affiliation Malankara Orthodox Syrian Christian Medical College, Kolenchery Address MOSC medical college, Kolenhery, Ernakulam District, PIN 682311 Ernakulam KERALA 682311 India Phone 8547787030 Fax 4842760409 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Anna Mathew Query) Designation Professor Research Coordinator Affiliation MOSC Medical College Address Department of Pharmacology, MOSC medical college, Kolenchery, Ernakulam District, PIN 682311 Department of Pharmacology, MOSC medical college, Kolenchery, Ernakulam District, PIN 682311 Ernakulam KERALA 682311 India Phone 9442221950 Fax 4842760409 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Anna Mathew Designation Professor Research Coordinator Affiliation MOSC Medical College Address Department of Pharmacology, MOSC medical college, Kolenchery, Ernakulam District, PIN 682311 Department of Pharmacology, MOSC medical college, Kolenchery, Ernakulam District, PIN 682311 Ernakulam KERALA 682311 India

page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in

Phone 9442221950 Fax 4842760409 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > ICMR Short Term Studentship, Ansari Nagar, New Delhi, Delhi 110029 Primary Sponsor Primary Sponsor Details Name MOSC Medical College Address MOSC Medical College, Kolenchery, Ernakulam District, Kerala PIN 682311 Type of Sponsor Private medical college Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Deepa Anne Thomas ECHS Polyclinic Room number 1,ECHS 8547787030 Poly clinic building, 4842760409 West Fort Mavelikara, [email protected] Alappuzha District PIN n 690101 Alappuzha KERALA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 18/01/2016 No Committee, MOSC Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Elderly patients above the age of 60 years who are on 5 or more concurrent regular medications. Intervention / Type Name Details Comparator Agent Intervention Group A MMAS-8 given. Proposed educational package including interactive teaching session, a handout and an O-KIT given. The teaching session was 10 minutes and given once for each patient. Comparator Agent Group B MMAS-8 given.No interactive teaching session, handout or OKIT given. Inclusion Criteria Inclusion Criteria Age From 60.00 Year(s) Age To 85.00 Year(s) Gender Both Details 1. All ex-servicemen and their families who attended the clinic over the age of 60 years
2. All ex-servicemen and their families who are on 5 or more regular drugs.

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Exclusion Criteria Exclusion Criteria Details 1. Ex-servicemen and their family members who are below the age of 60. 2. Ex-servicemen and their families who are unable to give clear account of themselves, unable to read or understand the questionnaire with the assumption that they will not be able to use the tool kit effectively. Method of Generating Permuted block randomization, fixed Random Sequence Method of Sequentially numbered, sealed, opaque envelopes Concealment Blinding/Masking Outcome Assessor Blinded Primary Outcome Outcome Timepoints Improvement in medical adherence using Scores before the administration of the Morisky Medication Adherence Scale-8 after the educational package was measured with a administration of the proposed educational Pre-intervention MMAS-8 in June 2016, after package showed a mean increase of 1.5 from which the intervention was given and a the pre-interventional score. Post-intervention MMAS-8 was given to them after 2 months. Learning scores assessd. Secondary Outcome Outcome Timepoints Determination of the prevalence of adherence to Total treatment adherence scores collected from prescribed medication in an elderly group of all the recruited subjects in the duration of 2 subjects. months was done from 20/06/16-23/08/16. Target Sample Size Total Sample Size=64 Sample Size from India=64 Final Enrollment numbers achieved (Total)=64 Final Enrollment numbers achieved (India)=64 Phase of Trial N/A Date of First 20/06/2016 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=2 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details None yet Brief Summary The study is aimed towards ’optimising’ the use of prescribed medications in a group of elderly subjects using the principles of Information, Instruction and Organisation (Woodruff et al). Methodology : The details of the study will be explained to the veterans and written informed consent will be taken from each participant recruited into the study. Participants recruited into the study will be assigned to one of the two groups of the study using permutation block randomisation with allocation concealment from student investigator. Pre MMAS-8 is administered to all. Only one group (Group A) receives the educational package- including an interactive teaching session, a handout and the OKIT, the other (Group B) remains as the control group. Post MMAS-8 is administered.

The intervention planned is an educational package consisting of

1) An interactive teaching session on drug adherence to give information about the need for the drug.

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2) A handout giving instruction about taking medication regularly and

3) An optimising kit (O-kit) to enable them to organise their medication schedule.

The Moriskey Medication Adherence Scale -8 is used to measure the level of adherence to prescribed medication.

The demographic variables in the two groups are compared using Chi square test. Later, the learning scores from the MMAS-8 will be compared using Wilcoxon Mann Whitney Utest. The results will be used to observe and compare the difference in treatment adherence from their initial presentation. The study will be dealing with aspects such as prompt and accurate consumption of medicines, proper visibility of the company name and composition of the drug on the cover as well as prevention of drug automation.

Implication : To find out if the planned educational package will help elderly participants optimise their use of medication.

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