A Smartphone App on Medication Adherence (App)

June 6, 2023 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

The Effectiveness of a Smartphone App on Medication Adherence and Psychotic Symptoms and Cognitive Functions in Patients With Schizophrenia

This is an experimental study which aims to explore the effectiveness of a smartphone app for medication adherence (MedAdhere app) among schizophrenic patients for eight weeks.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Schizophrenia is a mental disorder that causes severe functional disabilities and imposes a heavy economic burden. Poor medication adherence is one of the major causes of relapse of psychiatric symptoms in schizophrenic patients. This is an experimental study which aims to explore the effectiveness of a smartphone app for medication adherence (MedAdhere app) among schizophrenic patients for eight weeks.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 80708
        • Kaohsiung Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Schizophrenia is a brain disorder that is possibly related to the reduction of neural connections in the prefrontal cortex or imbalances in dopaminergic neurons in brain. It can be induced by genetic, social, physiological, psychological, and other factors, resulting in cognitive, emotional, behavioural, and perception dysfunction.

At present, new generations of anti-psychotic drugs have become available, allow patients to stabilise their condition with less side effect by receiving regular drug treatment. However, medication non-adherence can cause disorder progression, compromise the patient's quality of life, and increase medical expenses

Description

Inclusion Criteria:

  • schizophrenia
  • aged 20 to 65 years
  • able to read traditional Chinese
  • owning a smartphone
  • currently admitted at a psychiatric day-care center

Exclusion Criteria:

  • Intellectually disabled or severe cognitive function impairment (Dementia)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control group
The control group only received usual care, the PANSS and MMSE were used to assess psychiatric symptoms and cognitive functions before (week 0) and after 8 weeks.
experimental group
The experimental group use the MedAdhere app for eight weeks, the PANSS and MMSE were used to assess psychiatric symptoms and cognitive functions before (week 0) and after (week 8) intervention.
Behavioral: the MedAdhere app
The experimental group downloaded and used the MedAdhere app on their personal smartphones during this 8-week study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
psychiatric symptoms
Time Frame: Change from Baseline psychiatric symptoms at 8 weeks

The positive and negative syndrome scale was used to measure participants' psychiatric symptoms.

Of the 30 items on the scale, seven are positive symptoms, seven are negative symptoms, and 16 are general psychopathology symptoms. Symptom severity for each item is rated according to the anchoring points in the 7-point scale (1 = absent; 7 = extreme) that best describe the symptom (Kay et al., 1987). The PANSS score is the sum of ratings across items, ranging from 7 to 49 for the Positive, Negative Scales, and 16 to 112 and 16 to 112 for the General Psychopathology Scale.
Change from Baseline psychiatric symptoms at 8 weeks
cognitive functions
Time Frame: Change from Baseline cognitive functions at 8 weeks

The Mini-Mental State Examination was used to measure participants' cognitive functions.

The MMSE consists of 15 questions for assessing the following seven cognitive domains: orientation in time and place, memory registration and recall, attention and calculation, and language. The total MMSE score ranged from 0 to 30, and higher scores indicate better cognitive functions.
Change from Baseline cognitive functions at 8 weeks
Medication adherence rate
Time Frame: Change from Baseline Medication adherence' rate at 8 weeks
Utilizing cloud-based platforms to compute the medication adherence rate.
Change from Baseline Medication adherence' rate at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2023

Primary Completion (Estimated)

July 25, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KMURCT20200096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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