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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05892120
Other study ID # KMURCT20200096
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date December 31, 2023

Study information

Verified date May 2023
Source Kaohsiung Medical University Chung-Ho Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 100
Est. completion date December 31, 2023
Est. primary completion date July 25, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
the MedAdhere app
The experimental group downloaded and used the MedAdhere app on their personal smartphones during this 8-week study

Locations

Country Name City State
Taiwan Kaohsiung Medical University Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary psychiatric symptoms 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
Primary cognitive functions 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
Primary Medication adherence rate Utilizing cloud-based platforms to compute the medication adherence rate. Change from Baseline Medication adherence' rate at 8 weeks
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