Theory Based Integrated Program on Medication Adherence Among Community Dwelling Schizophrenia

NCT ID: NCT05835583

Last Updated: 2023-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-12-01

Brief Summary

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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

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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

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Schizophrenia Medication Adherence Medication Compliance

Keywords

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Schizophrenia, Medication Adherence, Randomized control trail,community, schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

The theory based integrated program

Intervention Type BEHAVIORAL

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.

control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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The theory based integrated program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia group, including schizophrenia, affective schizophrenia (schizoaffective disorder);
2. Age between 20 and 64 years old;
3. At least one oral antipsychotic drugs;
4. 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;
5. Those who can communicate in Chinese and Taiwanese

Exclusion Criteria

1. Those who have a diagnosis related to organic problems, substance abuse, dementia or mental retardation, and are unable to communicate;
2. Those who have received long-acting injections from the psychiatric department. -
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Science and Technology Council

FED

Sponsor Role collaborator

National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Wen I Liu

Distinguished Professor and Dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liu Wen-I

Role: PRINCIPAL_INVESTIGATOR

National Taipei University of Nursing and Health Sciences

Locations

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National Taipei University of Nursing and Health Sciences

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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The Integrated program

Identifier Type: -

Identifier Source: org_study_id