Theory Based Integrated Program on Medication Adherence Among Community Dwelling Schizophrenia

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.

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).

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Medication Adherence; Medication Compliance
• Intervention / Treatment: Behavioral: The theory based integrated program

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan, 112303
    • National Taipei University of Nursing and Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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	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	The time point of measurement is the baseline, the change in the 6th hour after the intervention, and the change in the 12th hour.

Collaborators and Investigators

• Sponsor: National Taipei University of Nursing and Health Sciences
• Collaborators: National Science and Technology Council
• Investigators: Principal Investigator: Liu Wen-I, National Taipei University of Nursing and Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Schizophrenia, Medication Adherence, Randomized control trail,community, schizophrenia
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: The Integrated program

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No