Theory Based Integrated Program on Medication Adherence Among Community Dwelling Schizophrenia

National Taipei University of Nursing and Health Sciences

Status: Completed

Conditions: Medication Adherence; Schizophrenia; Medication Compliance

Treatments: Behavioral: The theory based integrated program

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05835583

The Integrated program

Details and patient eligibility

About

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).

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups

experimental

Experimental group

Description:

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.

Treatment:

Behavioral: The theory based integrated program

control

No Intervention group

Description:

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.