Clinical trial NCT05835583: Theory Based Integrated Program on Medication Adherence Among Community Dwelling Schizophrenia
Official title: The Effectiveness of the Theory-based Integrated Program on Medication Adherence Among Community-dwelling Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Medication Adherence
Medication Compliance
Keywords: Schizophrenia, Medication Adherence, Randomized control trail,community, schizophrenia
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council
First posted: 2023-04-28
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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' 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.

Eligibility criteria: 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. -

Primary outcomes:
measure: Medication Adherence Rating Scale；MARS
timeFrame: The time point of measurement is the baseline, the change in the 6th hour after the intervention, and the change in the 12th hour.
measure: Brief Psychiatric Rating scale；BPRS
timeFrame: The time point of measurement is the baseline, the change in the 6th hour after the intervention, and the change in the 12th hour.
measure: University of Rhode Island Changed Assessment；URICA
timeFrame: The time point of measurement is the baseline, the change in the 6th hour after the intervention, and the change in the 12th hour.
measure: Drug Attitude Inventory，DAI-10
timeFrame: The time point of measurement is the baseline, the change in the 6th hour after the intervention, and the change in the 12th hour.
measure: Global Assessment of of Functioning, GAF
timeFrame: The time point of measurement is the baseline, the change in the 6th hour after the intervention, and the change in the 12th hour.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taipei University of Nursing and Health Sciences
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Liu Wen-I
role: PRINCIPAL_INVESTIGATOR
References: