- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07718334
Impact of a Mobile Application-Based Medication Reminder on Treatment Adherence Among Patients With Chronic Diseases and Memory Impairment: A Nursing Leadership Perspective
Impact of a Mobile Application-Based Medication Reminder on Treatment Adherence Among Patients With Chronic Diseases and Memory Impairment: A Nursing Leadership Perspective - A Quasi Experimental Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Improving medication adherence in patients with chronic illnesses and cognitive decline is a key priority in healthcare management and nursing administration. This quasi-experimental study utilizes a pretest-posttest design to examine the effectiveness of a mobile application-based reminder system designed specifically for patients experiencing memory impairment.
Participants will be selected based on specific inclusion criteria, including being diagnosed with a chronic disease and exhibiting mild-to-moderate memory impairment. Baseline assessments (pretest) will be conducted to measure initial medication adherence levels, patient demographics, and health status. Following the baseline phase, the intervention will be introduced, where participants will utilize the mobile application to receive automated medication alerts and reminders over a specified period. Evaluation (posttest) will be performed post-intervention to analyze changes in adherence rates. The findings are expected to provide insights into how nursing leadership can leverage mobile health (mHealth) technology to design supportive care pathways, enhance patient independence, and reduce clinical complications associated with poor treatment adherence.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Asmaa Elwan Hassan, PhD
- Phone Number: +201063776424
- Email: asmaaelwan@mans.edu.eg
Study Contact Backup
- Name: Mona Ahmed Gabr, PhD
- Phone Number: 201097898593
Study Locations
-
-
Dakahlia Governorate
-
Gamasa, Dakahlia Governorate, Egypt
- Recruiting
- Outpatient Clinics, Delta University for Science and Technology
-
Contact:
- Asmaa Elwan Hassan, PhD
- Phone Number: +201063776424
- Email: asmaaelwan@mans.edu.eg
-
Contact:
- Mona Ahmed Gabr, PhD
-
-
Kafr el-Sheikh Governorate
-
Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt
- Recruiting
- Outpatient Clinics, Kafr El-Sheikh Hospital
-
Contact:
- Asmaa Elwan Hassan, PhD
- Phone Number: +201063776424
- Email: asmaaelwan@mans.edu.eg
-
Contact:
- Mona Ahmed Gabr, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients diagnosed with one or more chronic diseases requiring regular long-term medication.
- Patients exhibiting mild-to-moderate memory impairment or cognitive decline as screened by the Mini-Mental State Examination (MMSE).
- Patients who personally own and are capable of operating a smartphone or have a primary caregiver willing to manage the mobile application.
- Patients aged 18 years and older.
- Patients who provide voluntary informed consent to participate in the study.
Exclusion Criteria:
- Patients with severe cognitive impairment or advanced dementia who cannot interact with mobile technology even with caregiver assistance.
- Patients with severe acute clinical complications or unstable psychiatric conditions.
- Patients participating in another concurrent clinical trial or study targeting medication adherence
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mobile Application Group
Participants in this single-group study will receive training on and utilize a customized mobile application-based medication reminder designed to support adherence to their therapeutic regimens.
|
The intervention consists of a mobile application specifically designed to support medication adherence.
It features automated push notifications, customized reminder alerts matching prescribed medication schedules, and tracking logs.
Participants will be instructed on how to install, configure, and use the application on their personal smartphones.
The system is designed to provide immediate prompts to overcome memory-related adherence barriers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medication Adherence (MMAS-8)
Time Frame: Baseline (pre-intervention) and 3 months post-intervention
|
Medication adherence will be assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8).
This self-reported tool evaluates patients' behaviors regarding taking their prescribed chronic medications.
Total scores range from 0 to 8, where a score of 8 indicates high adherence, 6 to <8 indicates medium adherence, and <6 indicates low adherence.
|
Baseline (pre-intervention) and 3 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective Medication Adherence: Medication Possession Ratio (MPR)
Time Frame: 3 months post-intervention
|
Medication Possession Ratio (MPR) will be calculated using pharmacy refill records to determine the proportion of time the patient has access to their prescribed medication during the study period.
Total scores will range from 0 to 1 (or 0% to 100%), with higher values indicating better adherence.
|
3 months post-intervention
|
|
Objective Medication Adherence: Proportion of Days Covered (PDC)
Time Frame: 3 months post-intervention
|
Proportion of Days Covered (PDC) will be assessed using pharmacy refill records to measure the percentage of days the patient covered their prescribed medication dosage over the study duration.
Total scores will range from 0 to 1 (or 0% to 100%), where higher values reflect superior medication adherence.
|
3 months post-intervention
|
|
Cognitive Function Status (MMSE)
Time Frame: Baseline
|
Cognitive impairment levels will be screened using the Mini-Mental State Examination (MMSE) to classify the severity of cognitive/memory impairment among participants.
|
Baseline
|
|
Perceived Nursing Care and Leadership Support
Time Frame: 3 months post-intervention.
|
Evaluated using the Nursing Care and Leadership Support Assessment Tool to measure patient satisfaction and perception of the supportive role played by nursing leadership during the application-based program.
|
3 months post-intervention.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Pathologic Processes
- Disease Attributes
- Neurobehavioral Manifestations
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Treatment Adherence and Compliance
- Health Behavior
- Patient Compliance
- Patient Acceptance of Health Care
- Memory Disorders
- Chronic Disease
- Medication Adherence
Other Study ID Numbers
- DFM-IRB 00012367- 26-04-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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