Theory Based Integrated Program on Medication Adherence Among Community Dwelling Schizophrenia

NCT05835583 | Completed DMC

• 1 other identifier: The Integrated program
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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).

Conditions

Schizophrenia; Medication Adherence; Medication Compliance

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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.

Study Arms (2)

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

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.

Interventions

The theory based integrated program 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.

experimental

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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. -

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead
• National Science and Technology Council: collaborator

Study Sites (1)

National Taipei University of Nursing and Health Sciences

Taipei, 112303, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia; Medication Adherence

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Liu Wen-I

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor and Dean

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: April 28, 2023
• Study Start: August 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

TW (1)