| CTRI Number |
CTRI/2024/01/061975 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
13/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Other (Specify) [App for improving medical adherence and manual pill organiser] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of smart phone app and manual pill organizer to improve the medicine pill compliance in elderly participants |
|
Scientific Title of Study
|
Effectiveness of using manual pill organizers and pill reminder apps in improving medication adherence and health outcomes in elderly patients receiving multiple medications |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Apte |
| Designation |
Consultant clinical pharmacologist and Senior medical scientist |
| Affiliation |
Vadu Rural Health Program, KEM Hospital Research centre |
| Address |
KEM Hospital Research Centre, TDH Building 3rd floor,
KEM Hospital,
Rasta Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
919975950227 |
| Fax |
|
| Email |
aditi.apte@kemhrcvadu.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditi Apte |
| Designation |
Consultant clinical pharmacologist and Senior medical scientist |
| Affiliation |
Vadu Rural Health Program, KEM Hospital Research centre |
| Address |
KEM Hospital Research Centre, TDH Building 3rd floor,
KEM Hospital,
Rasta Peth, Pune
MAHARASHTRA
411011
India |
| Phone |
919975950227 |
| Fax |
|
| Email |
aditi.apte@kemhrcvadu.org |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Apte |
| Designation |
Consultant clinical pharmacologist and Senior medical scientist |
| Affiliation |
Vadu Rural Health Program, KEM Hospital Research centre |
| Address |
KEM Hospital Research Centre, TDH Building 3rd floor,
KEM Hospital,
Rasta Peth, Pune
MAHARASHTRA
411011
India |
| Phone |
919975950227 |
| Fax |
|
| Email |
aditi.apte@kemhrcvadu.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Department of Health Research, Ministry of health and family welfare, Government of India, New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Maj Dr Bhupendra Solanke |
Armed Forces Medical College |
Department of Pharmacology, AFMC, Southern Command, Solapur - Pune Hwy, near Race Course, Wanowrie, Pune
Pune
MAHARASHTRA |
09923693597
drbhupis@gmail.com |
| Dr Farah Naaz Fathima |
St John Medical College |
Department of Community Medicine, St John Medical College, Sarjapur Road, Bengauru
Bangalore
KARNATAKA |
09886894586
doc.farah@gmail.com |
| Dr Aditi Apte |
Vadu Rural Health Program |
Shirdi Sai Baba Rural Hospital, Vadu Bk; Taluka Shirur
Pune
MAHARASHTRA |
9975950227
aditi.apte@kemhrcvadu.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , ST JOHNS MEDICAL COLLEGE HOSPITAL |
Approved |
| Institutional Ethics Committee Armed Forces Medical College |
Approved |
| KEM Hospital Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: J44||Other chronic obstructive pulmonary disease, (3) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 2 Patient education + Manual pill organiser
Group 3 – Patient education + Pill reminder app
Group 4 – Patient education + Pill reminder app + Manual pill organiser
|
The intervention will be for 12 months
Group 2- In addition to patient education, weekly manual pill organisers will be provided to all participants from Group 2 to sort their medications.
Group 3-In addition to patient education for all participants of group 3 Pill reminder app will be installed in the smart phones
Group 4-In addition to patient education and manual pill organiser, Pill reminder app will be installed in the smart phones of participants its use will be demonstrated at baseline.
|
| Comparator Agent |
Group1-Patient education |
Behavioural counselling and education about timely consumption of medications will be done for all participants at baseline through a counselling session and a medication adherence information leaflet. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
-Medically stable elderly individuals aged 60-80 years diagnosed with one or more noncommunicable diseases (E.g. hypertension, diabetes, hypercholesteremia, bronchial asthma, chronic obstructive lung disease)
-Prescribed with three or more oral medications for at least past 6 months and are able to self-administer the medications.
b. Planning to stay in the study area for next one year.
c. Access to a smartphone within the family throughout the day and knowledge to use it.
d. Willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
-History of hospitalisation during last one month
-Individuals diagnosed with any mental or cognitive dysfunction (e.g. Schizophrenia, Alzheimer’s disease)
-Individuals with expected life expectancy of less than one year (e.g. severe debility due to advanced age, advanced stage malignant cancers)
-Used pill organiser or pill reminder app for improving medication adherence in the past.
-Any other condition that in the opinion of the investigator jeopardises the health and wellbeing of the participant in case of participation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Assessment of medication adherence using Medication adhrence rating system - 5 (MARS-5), Self reported seven days point prevalence of medication non-adherence and pill count. |
MARS-5 and seven days point prevelence of medication non-adhrence will be assessed at 3, 6 and 12 months. Pill counts will be assessed at the end of each quarter during 12 months follow up. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Assessment of acceptability and barriers for the use of manual pill organisers and pill reminder apps |
The acceptability and barriers will be evaluated through the qualitative study in phase 1.
Additionally, systems usability scale (SUS) will be used for assessment of usability of the manual pill organisers and pill reminder app. |
| Health care utilisation |
Number of hospitalisation or emergency department visits or outpatient visits or general practitioner visits will be measured at 3,6 and 12 months |
| Adverse clinical outcomes |
Any clinically significant events that may impact on healthcare utilisation and mortality (at 3, 6 and 12 months) |
| Quality of Life, cost effectiveness & cost-utility ratio |
Quality of life will be assessed at baseline & 12 months using EQ5D5L. Cost for development of each study intervention will be calculated. Cost-effectiveness will be calculated against the primary outcome of medication adherence. The incremental cost-utility ratio will be calculated as additional cost required to have unit change in the quality of life. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="752"
Sample Size from India="752"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2024 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Nimkar RK, Balkhande RW, Patil RS, Agarwal DM, Apte AA. Evaluation of acceptability and feasibility of using manual pill organizers and pill reminder apps for improving medication adherence among elderly population from rural Maharashtra. Indian J Pharmacol. 2025 May 1;57(3):150-158. doi: 10.4103/ijp.ijp_960_24. Epub 2025 Jul 9. PMID: 40632091; PMCID: PMC12348747.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Title: Effectiveness of using manual pill organizers and/or pill reminder apps in improving medication adherence and health outcomes in elderly patients receiving multiple medications Background: Approximately 40-75% of the elderly individuals suffering from chronic diseases have been found to be nonadherent to treatment. There is no evidence on effectiveness of pill organisers and pill reminder apps in Indian geriatric population. Study objectives: The primary objective is to assess effectiveness of pill organisers and pill reminder apps singly or in combination for improving medication adherence in elderly patients receiving multiple medications. Additionally, we will evaluate the feasibility of use and impact on health utilization, adverse clinical outcomes and cost-utility. Methods: Study population will include medically stable elderly participants aged 60-80 years diagnosed with one or more noncommunicable diseases, receiving 3 or more medications for the past 6 months and willing to participate in the study. The phase 1 study will pilot test feasibility and acceptability of the interventions in 60 participants using mixed methods and will be conducted at VRHP, KEMHRC, Pune. Based on the results of this study the pill box and pill reminder app will be optimized for the next phase. Phase 2 will be a randomised open-labelled study to evaluate the impact of manual pill organisers and/or pill reminder app in 752 elderly population on medication adherence, health, and quality of life. The participants will be followed up at 3, 6 and 12 months for medication adherence outcomes, health outcome, quality of life and cost-utility outcomes. Endpoints: · Change in medication adherence [measured using medication adherence rating scale (MARS-5)], Seven days point prevalence and pill count at baseline, 3, 6 and 12 months · Assessment of acceptability and barriers in the use of manual pill organisers and pill reminder apps alone or in combination amongst elderly population · Health care utilization (hospitalization, emergency department visits, outpatient visits and general practitioner visits) at 3,6 and 12 months · Adverse clinical outcomes at 3, 6 and 12 months · Quality of life (using EQ5D5L) at baseline and 12 months. · Incremental cost effectivenss and cost utility ratio at baseline and 12 months. Expected outcome and impact: The study will provide definitive evidence on the use of pill organisers and pill reminder apps in Indian geriatric population in terms of improvement in medication adherence as well as health and economic outcomes. |