Medication AdherenceAppNCT05892120
A Smartphone App on Medication Adherence
An observational study of Medication Adherence, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence
- What is being tested?
- the MedAdhere app
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2023to 31 Dec 2023
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- schizophrenia
- aged 20 to 65 years
- able to read traditional Chinese
- owning a smartphone
- currently admitted at a psychiatric day-care center
Who cannot join
- Intellectually disabled or severe cognitive function impairment (Dementia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Medication Adherence
- Being tested
- the MedAdhere app
- Keywords
- schizophrenia, medication adherence, smartphone app, psychiatric symptoms
- Medical subject headings
- Medication Adherence, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the MedAdhere appBehavioural
The experimental group downloaded and used the MedAdhere app on their personal smartphones during this 8-week study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: the MedAdhere app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline psychiatric symptoms at 8 weeks
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.
Measured: Change from Baseline cognitive functions at 8 weeks
Medication adherence rate
Utilizing cloud-based platforms to compute the medication adherence rate.
Measured: Change from Baseline Medication adherence' rate at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Jun 2023 (estimated)
- Primary completion25 Jul 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892120
- Sponsor's protocol ID
- KMURCT20200096
- Acronym
- App
- Status last verified
- May 2023
- First submitted
- 16 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen HH, Hsu HT, Lin PC, Chen CY, Hsieh HF, Ko CH. Efficacy of a Smartphone App in Enhancing Medication Adherence and Accuracy in Individuals With Schizophrenia During the COVID-19 Pandemic: Randomized Controlled Trial. JMIR Ment Health. 2023 Dec 14;10:e50806. doi: 10.2196/50806.
PubMed 38096017
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Smartphone App on Medication Adherence and Psychotic Symptoms and Cognitive Functions in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT05892120
- Acronym / sponsor ID
- App / KMURCT20200096
- Conditions
- Medication Adherence
- Keywords
- schizophrenia, medication adherence, smartphone app, psychiatric symptoms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 25 Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Behavioral: the MedAdhere appThe 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- schizophrenia
- aged 20 to 65 years
- able to read traditional Chinese
- owning a smartphone
- currently admitted at a psychiatric day-care center
Key exclusion criteria (1 listed)
- Intellectually disabled or severe cognitive function impairment (Dementia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the MedAdhere appThe experimental group downloaded and used the MedAdhere app on their personal smartphones during this 8-week study | Behavioural | experimental group |
Primary outcome
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.
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.
Medication adherence rate
Time frame: Change from Baseline Medication adherence' rate at 8 weeks
Utilizing cloud-based platforms to compute the medication adherence rate.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Derived from this study: PubMed 38096017Chen HH, Hsu HT, Lin PC, Chen CY, Hsieh HF, Ko CH. Efficacy of a Smartphone App in Enhancing Medication Adherence and Accuracy in Individuals With Schizophrenia During the COVID-19 Pandemic: Randomized Controlled Trial. JMIR Ment Health. 2023 Dec 14;10:e50806. doi: 10.2196/50806.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Adherence, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychiatric symptoms (time frame: Change from Baseline psychiatric symptoms at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05892120, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.