A Smartphone App on Medication Adherence

Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05892120
Collaborator
(none)
100
1
7
14.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: the MedAdhere app

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
The Effectiveness of a Smartphone App on Medication Adherence and Psychotic Symptoms and Cognitive Functions in Patients With Schizophrenia
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jul 25, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. psychiatric symptoms [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.

  2. cognitive functions [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.

  3. Medication adherence rate [Change from Baseline Medication adherence' rate at 8 weeks]

    Utilizing cloud-based platforms to compute the medication adherence rate.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kaohsiung Medical University Kaohsiung Taiwan 80708

Sponsors and Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT05892120
Other Study ID Numbers:
  • KMURCT20200096
First Posted:
Jun 7, 2023
Last Update Posted:
Jun 7, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital

Study Results

No Results Posted as of Jun 7, 2023