SchizophreniaNCT05835583
Theory Based Integrated Program on Medication Adherence Among Community Dwelling Schizophrenia
A study testing The theory based integrated program in people with Schizophrenia and Medication Adherence, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
This clinical trial aims to evaluate the effectiveness of the theory-based integrated program in promoting medication adherence in patients with schizophrenia. The purpose of this study are: To explore the effectiveness of the theory-based integrated program in promoting community-based schizophrenia patients'… Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Schizophrenia, Medication Adherence, Medication Compliance
- What is being tested?
- The theory based integrated program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2021to 1 Dec 2022
- Phase
- Interventional
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia group, including schizophrenia, affective schizophrenia (schizoaffective disorder);
- Age between 20 and 64 years old;
- At least one oral antipsychotic drugs;
- Living in the community, not participating in day wards, community rehabilitation centers and other rehabilitation institutions on weekdays, no psychiatric outpatient clinics, only home visits by home nurses;
- Those who can communicate in Chinese and Taiwanese
Who cannot join
- Those who have a diagnosis related to organic problems, substance abuse, dementia or mental retardation, and are unable to communicate;
- Those who have received long-acting injections from the psychiatric department. -
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taipei University of Nursing and Health Sciences
Taipei, 112303
About this study
Official title: The Effectiveness of the Theory-based Integrated Program on Medication Adherence Among Community-dwelling Patients With Schizophrenia
This clinical trial aims to evaluate the effectiveness of the theory-based integrated program in promoting medication adherence in patients with schizophrenia. The purpose of this study are:
- To explore the effectiveness of the theory-based integrated program in promoting community-based schizophrenia patients' adherence to medication(like :motivation, attitude and behavior)
- To explore the effectiveness of the theory-based integrated program in improving the psychiatric symptoms of patients with schizophrenia in the community.
Read more
Participants (the experimental group) received routine home visits from psychiatric mental nurses, including drug administration, drug side effects and symptom management, life care, and the theory-based program provided by the researcher(treatment as usual + the theory-based integrated program).
The comparison group: received routine home visits from psychiatric mental nurses, including drug administration, drug side effects, and symptom management, life care,(treatment as usual).
Read the detailed description
Members of the experimental group received routine home visits, plus a 1-hour the theory-based program intervention 12 times in the 1st, 3rd, 5th, 7th, 9th, 11th, 13th, 15th, 17th, 19th, 21st, and 23rd weeks, and each patient received a total of 12 hours of intervention.
The control group received routine home visits by psychiatric mental nurses, and the nurse provided patients with answers to questions about medications or care and handling of life events. The visits and intervention time frequency were the same as those in the experimental group.
Both groups were received baseline (T0), after the 6th hours intervention (T1) and 12th hours intervention by nurses to collect data on the main outcome variables: adherence to medication, mental symptoms, motivation to take medication, and attitude towards medication.
- Conditions
- Schizophrenia, Medication Adherence, Medication Compliance
- Being tested
- The theory based integrated program
- Keywords
- Schizophrenia, Medication Adherence, Randomized control trail,community, schizophrenia
- Medical subject headings
- Schizophrenia, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The theory based integrated programBehavioural
The theory-based integrated program is administered by a nurse trained in motivational interviewing.In the 12-hour intervention, this program uses motivational interviewing skills to increase the patient's attitude towards medication, enhance the support of significant others around them, and increase the patient's control over their own behavior.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Members of the experimental group received routine home visits( by psychiatric mental nurses, and the nurse provided patients with answers to questions about medications or care and handling of life events), and plus a 1-hour theory based integrated program intervention for 12 times in the 1st, 3rd, 5th, 7th, 9th, 11th, 13th, 15th, 17th, 19th, 21st, and 23rd weeks, and each patient received a total of 12 hours of intervention. Receives: Behavioral: The theory based integrated program |
| control | No intervention | The control group received routine home visits by psychiatric mental nurses, and the nurse provided patients with answers to questions about medications or care and handling of life events. The visits and intervention time frequency were the same as those in the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence Rating Scale；MARS
The Medication Adherence Rating Scale(MARS) is a 10-item self-reporting multidimensional instrument describing three dimensions: medication adherence behavior (items 1-4), attitude toward taking medication (items 5-8) and negative side effects and attitudes to psychotropic medication (items 9-10). sponse consistent with non-adherence is coded as 0, whereas a response consistent with adherence is coded as 1. For questions 1-6 and 9-10, a no response is indicative of adherence and is coded as 1, while for questions 7 and 8, a yes response is indicative of adherence and is coded as 1. Total scores on the MARS may range between 0 and 10, with a higher score indicating better medication adherence.
Measured: The time point of measurement is the baseline, the change in the 6th hour after the intervention, and the change in the 12th hour.
Brief Psychiatric Rating scale；BPRS
The Brief Psychiatric Rating scale(BPRS) assesses the level of 18 symptom constructs such as hostility, suspiciousness, hallucination, and grandiosity. It is particularly useful in gauging the efficacy of treatment in patients who have moderate to severe psychoses.Total scores on the MARS may range between 0 and 10, with a higher score indicating better medication adherence.This scale is scored from 0-6, with a total of 16 items, and the total score ranges from 0 to 96. The higher the score, the more obvious the psychiatric symptoms
Measured: The time point of measurement is the baseline, the change in the 6th hour after the intervention, and the change in the 12th hour.
University of Rhode Island Changed Assessment；URICA
The University of Rhode Island Change Assessment Scale (URICA) is a 32 item self-report measure that includes 4 subscales measuring the stages of change: Precontemplation, Contemplation, Action, and Maintenance (there is also a 24 item version). Responses are given on a 5 point Likert scale ranging from (1=strong disagreement to 5=strong agreement),Calculate the score with its calculation formula, and get a score ranging from -2 to 14. The higher the score, the stronger the motivation to change.
Measured: The time point of measurement is the baseline, the change in the 6th hour after the intervention, and the change in the 12th hour.
Drug Attitude Inventory，DAI-10
The Drug Attitude Inventory(DAI-10) contains six items that a patient who is fully adherent to prescribed medication would answer as 'True', and four they would rate as 'False'. Scores are allocated to each answer and the total score is calculated in the same way as for the DAI-30. The range is -4 to 6 points. The higher the score, the more positive the attitude of taking the medicine, with 0 points as the cut-off point, above 0 means the attitude of taking the medicine is positive; below 0 means the attitude of taking the medicine is negative
Measured: The time point of measurement is the baseline, the change in the 6th hour after the intervention, and the change in the 12th hour.
Global Assessment of of Functioning, GAF
The Global Assessment of Functioning, or GAF, scale is used to rate how serious a mental illness may be. It measures how much a person's symptoms affect their day-to-day life on a scale of 0 to 100.The higher the score, the better the function. A score above 81 means good function, a score below 50 means serious difficulty in function, and a score of 0 means insufficient information
Measured: The time point of measurement is the baseline, the change in the 6th hour after the intervention, and the change in the 12th hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 Aug 2021
- Primary completion1 Nov 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council
- Responsible party
- Principal investigator, Wen I Liu, National Taipei University of Nursing and Health Sciences
- Investigators
- Liu Wen-I, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835583
- Sponsor's protocol ID
- The Integrated program
- Status last verified
- Apr 2023
- First submitted
- 11 Jan 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Theory-based Integrated Program on Medication Adherence Among Community-dwelling Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT05835583
- Acronym / sponsor ID
- The Integrated program
- Conditions
- Schizophrenia, Medication Adherence, Medication Compliance
- Keywords
- Schizophrenia, Medication Adherence, Randomized control trail,community, schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- National Science and Technology Council
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 28 Apr 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 clinical trial aims to evaluate the effectiveness of the theory-based integrated program in promoting medication adherence in patients with schizophrenia. The purpose of this study are:
- To explore the effectiveness of the theory-based integrated program in promoting community-based schizophrenia patients' adherence to medication(like :motivation, attitude and behavior)
- To explore the effectiveness of the theory-based integrated program in improving the psychiatric symptoms of patients with schizophrenia in the community.
Participants (the experimental group) received routine home visits from psychiatric mental nurses, including drug administration, drug side effects and symptom management, life care, and the theory-based program provided by the researcher(treatment as usual + the theory-based integrated program).
The comparison group: received routine home visits from psychiatric mental nurses, including drug administration, drug side effects, and symptom management, life care,(treatment as usual).
Detailed description
Members of the experimental group received routine home visits, plus a 1-hour the theory-based program intervention 12 times in the 1st, 3rd, 5th, 7th, 9th, 11th, 13th, 15th, 17th, 19th, 21st, and 23rd weeks, and each patient received a total of 12 hours of intervention.
The control group received routine home visits by psychiatric mental nurses, and the nurse provided patients with answers to questions about medications or care and handling of life events. The visits and intervention time frequency were the same as those in the experimental group.
Both groups were received baseline (T0), after the 6th hours intervention (T1) and 12th hours intervention by nurses to collect data on the main outcome variables: adherence to medication, mental symptoms, motivation to take medication, and attitude towards medication.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Behavioral: The theory based integrated programMembers of the experimental group received routine home visits( by psychiatric mental nurses, and the nurse provided patients with answers to questions about medications or care and handling of life events), and plus a 1-hour theory based integrated program intervention for 12 times in the 1st, 3rd, 5th, 7th, 9th, 11th, 13th, 15th, 17th, 19th, 21st, and 23rd weeks, and each patient received a total of 12 hours of intervention. |
| control | No intervention | –The control group received routine home visits by psychiatric mental nurses, and the nurse provided patients with answers to questions about medications or care and handling of life events. The visits and intervention time frequency were the same as those in the experimental group. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia group, including schizophrenia, affective schizophrenia (schizoaffective disorder);
- Age between 20 and 64 years old;
- At least one oral antipsychotic drugs;
- Living in the community, not participating in day wards, community rehabilitation centers and other rehabilitation institutions on weekdays, no psychiatric outpatient clinics, only home visits by home nurses;
- Those who can communicate in Chinese and Taiwanese
Key exclusion criteria (2 listed)
- Those who have a diagnosis related to organic problems, substance abuse, dementia or mental retardation, and are unable to communicate;
- Those who have received long-acting injections from the psychiatric department. -
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 theory based integrated programThe theory-based integrated program is administered by a nurse trained in motivational interviewing.In the 12-hour intervention, this program uses motivational interviewing skills to increase the patient's attitude towards medication, enhance the support of significant others around them, and increase the patient's control over their own behavior. | Behavioural | experimental |
Primary outcome
Medication Adherence Rating Scale；MARS
Time frame: The time point of measurement is the baseline, the change in the 6th hour after the intervention, and the change in the 12th hour.
The Medication Adherence Rating Scale(MARS) is a 10-item self-reporting multidimensional instrument describing three dimensions: medication adherence behavior (items 1-4), attitude toward taking medication (items 5-8) and negative side effects and attitudes to psychotropic medication (items 9-10). sponse consistent with non-adherence is coded as 0, whereas a response consistent with adherence is coded as 1. For questions 1-6 and 9-10, a no response is indicative of adherence and is coded as 1, while for questions 7 and 8, a yes response is indicative of adherence and is coded as 1. Total scores on the MARS may range between 0 and 10, with a higher score indicating better medication adherence.
Brief Psychiatric Rating scale；BPRS
Time frame: The time point of measurement is the baseline, the change in the 6th hour after the intervention, and the change in the 12th hour.
The Brief Psychiatric Rating scale(BPRS) assesses the level of 18 symptom constructs such as hostility, suspiciousness, hallucination, and grandiosity. It is particularly useful in gauging the efficacy of treatment in patients who have moderate to severe psychoses.Total scores on the MARS may range between 0 and 10, with a higher score indicating better medication adherence.This scale is scored from 0-6, with a total of 16 items, and the total score ranges from 0 to 96. The higher the score, the more obvious the psychiatric symptoms
University of Rhode Island Changed Assessment；URICA
Time frame: The time point of measurement is the baseline, the change in the 6th hour after the intervention, and the change in the 12th hour.
The University of Rhode Island Change Assessment Scale (URICA) is a 32 item self-report measure that includes 4 subscales measuring the stages of change: Precontemplation, Contemplation, Action, and Maintenance (there is also a 24 item version). Responses are given on a 5 point Likert scale ranging from (1=strong disagreement to 5=strong agreement),Calculate the score with its calculation formula, and get a score ranging from -2 to 14. The higher the score, the stronger the motivation to change.
Drug Attitude Inventory，DAI-10
Time frame: The time point of measurement is the baseline, the change in the 6th hour after the intervention, and the change in the 12th hour.
The Drug Attitude Inventory(DAI-10) contains six items that a patient who is fully adherent to prescribed medication would answer as 'True', and four they would rate as 'False'. Scores are allocated to each answer and the total score is calculated in the same way as for the DAI-30. The range is -4 to 6 points. The higher the score, the more positive the attitude of taking the medicine, with 0 points as the cut-off point, above 0 means the attitude of taking the medicine is positive; below 0 means the attitude of taking the medicine is negative
Global Assessment of of Functioning, GAF
Time frame: The time point of measurement is the baseline, the change in the 6th hour after the intervention, and the change in the 12th hour.
The Global Assessment of Functioning, or GAF, scale is used to rate how serious a mental illness may be. It measures how much a person's symptoms affect their day-to-day life on a scale of 0 to 100.The higher the score, the better the function. A score above 81 means good function, a score below 50 means serious difficulty in function, and a score of 0 means insufficient information
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
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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.
Liu Wen-I principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The theory based integrated program in people with Schizophrenia and Medication Adherence, run by National Taipei University of Nursing and Health Sciences 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 2 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: finished, as of the sponsor's last update on 28 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Medication Adherence Rating Scale；MARS (time frame: The time point of measurement is the baseline, the change in the 6th hour after the intervention, and the change in the 12th hour.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2023.