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NCT05304780 Clinical Trial

Needs-tailored Nurse-led Recovery Program for Community-dwelling People With Schizophrenia

Schizophrenia Clinical Trial

Official title:
Effectiveness of a Needs-tailored Nurse-led Recovery Program for Community-dwelling People With Schizophrenia: A Cluster-randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05304780
Other study ID # needs-tailored
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 15, 2020
Est. completion date December 31, 2021

Study information
Verified date January 2024
Source National Taipei University of Nursing and Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Meeting people's needs is positively correlated with their recovery. However, recovery services rarely include nurse-led programs tailored to the needs of these people. This study aimed to evaluate the effectiveness of a new needs-tailored recovery program by using a cluster-randomized controlled trial design.

Description:

First year, investigators used the pilot study to test the needs tailored recovery program feasibility, acceptability and preliminary usefulness of the needs-tailored nurse-led recovery program. In the second year, based on the findings of the pilot study, a cluster randomized controlled trial was conducted to assess the effectiveness of the needs-tailored nurse-led recovery program in two psychiatric centers in northern Taiwan. The treatment group receive the needs-tailored nurse-led recovery program by their home-care nurses over 6 months. The control group receive the usual community psychiatric care only. Data were collected before the intervention, after the intervention, and at a follow-up session three months after the end of the intervention period. The outcomes were recovery, needs, hope, empowerment, psychotic symptoms, and medication adherence. The investigators used repeated measures ANOVA tests to examine the effect of the group × time interaction.

Recruitment information / eligibility
Status Completed
Enrollment 164
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 64 Years
Eligibility Inclusion Criteria: - were living in the community and had a diagnosis of schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) - were aged 20-64 years - were able to communicate in Mandarin or Taiwanese. Exclusion Criteria: - were living in a community institution such as a recovery home, community rehabilitation center, nursing home, or day hospital - had a neurocognitive disorder, substance abuse disorder, or comorbidity.

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• needs-tailored nurse-led recovery program
The needs-tailored nurse-led recovery program were divided into five major stages of care, which were build partnership, conduct integrated needs assessment, set needs-based recovery goals and provide empowerment-oriented care, conduct continuous monitoring of goals, and conduct effectiveness evaluations.

Locations
Country Name City State
Taiwan National Taipei University of Nursing and Health Sciences Taipei City

Sponsors (2)
Lead Sponsor Collaborator
National Taipei University of Nursing and Health Sciences National Science and Technology Council

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change scores of Questionnaire about the Process of Recovery Participants will complete the Questionnaire about the Process of Recovery (QPR). It is total of 22 questions in this scale to evaluate recovery score.Each question is scored from 0-4 points.The higher scores mean a better outcome. baseline
Primary Change scores of Questionnaire about the Process of Recovery Participants will complete the Questionnaire about the Process of Recovery (QPR). It is total of 22 questions in this scale to evaluate recovery score.Each question is scored from 0-4 points.The higher scores mean a better outcome. 6 months
Primary Change scores of Questionnaire about the Process of Recovery Participants will complete the Questionnaire about the Process of Recovery (QPR). It is total of 22 questions in this scale to evaluate recovery score.Each question is scored from 0-4 points.The higher scores mean a better outcome. 9 months
Secondary Change scores of Rogers Empowerment Scale Participants will complete the Empowerment Scale. It is total of 13 questions in this scale to evaluate empowerment score. Each question is scored from 1-4 points.The higher scores mean a better outcome. baseline
Secondary Change scores of Rogers Empowerment Scale Participants will complete the Empowerment Scale. It is total of 13 questions in this scale to evaluate empowerment score. Each question is scored from 1-4 points.The higher scores mean a better outcome. 6 months
Secondary Change scores of Rogers Empowerment Scale Participants will complete the Empowerment Scale. It is total of 13 questions in this scale to evaluate empowerment score. Each question is scored from 1-4 points.The higher scores mean a better outcome. 9 months
Secondary Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness Participants will complete the Needs Assessment Instrument for the Community-Dwelling People with Mental Illness. It is total of 22 questions in this scale to evaluate need. Each question is scored from 0-2 points. The higher the score, the greater the demand. baseline
Secondary Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness Participants will complete the Needs Assessment Instrument for the Community-Dwelling People with Mental Illness. It is total of 22 questions in this scale to evaluate need. Each question is scored from 0-2 points. The higher the score, the greater the demand. 6 months
Secondary Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness Participants will complete the Needs Assessment Instrument for the Community-Dwelling People with Mental Illness. It is total of 22 questions in this scale to evaluate need. Each question is scored from 0-2 points. The higher the score, the greater the demand. 9 months
Secondary Change scores of Herth Hope Index Participants will complete the Herth Hope Index (HHI). It is total of 12 questions in this scale to evaluate hope score.Each question is scored from 1-4 points.The higher scores mean a better outcome. baseline
Secondary Change scores of Herth Hope Index Participants will complete the Herth Hope Index (HHI). It is total of 12 questions in this scale to evaluate hope score.Each question is scored from 1-4 points.The higher scores mean a better outcome. 6 months
Secondary Change scores of Herth Hope Index Participants will complete the Herth Hope Index (HHI). It is total of 12 questions in this scale to evaluate hope score.Each question is scored from 1-4 points.The higher scores mean a better outcome. 9 months
Secondary Change scores of Medication Adherence Rating Scale Participants will complete the Medication Adherence Rating Scale (MARS). It is total of 10 questions in this scale to evaluate medication adherence score. Each question is scored from 0-1 points.The higher scores mean a better outcome. baseline
Secondary Change scores of Medication Adherence Rating Scale Participants will complete the Medication Adherence Rating Scale (MARS). It is total of 10 questions in this scale to evaluate medication adherence score. Each question is scored from 0-1 points.The higher scores mean a better outcome. 6 months
Secondary Change scores of Medication Adherence Rating Scale Participants will complete the Medication Adherence Rating Scale (MARS). It is total of 10 questions in this scale to evaluate medication adherence score. Each question is scored from 0-1 points.The higher scores mean a better outcome. 9 months
Secondary Change scores of Brief Psychiatric Rating Scale Participants will complete the Brief Psychiatric Rating Scale (BPRS). It is total of 16 questions in this scale to evaluate psychiatric symptom. Each question is scored from 0-6 points.The higher scores mean a worse outcome. baseline
Secondary Change scores of Brief Psychiatric Rating Scale Participants will complete the Brief Psychiatric Rating Scale (BPRS). It is total of 16 questions in this scale to evaluate psychiatric symptom. Each question is scored from 0-6 points.The higher scores mean a worse outcome. 6 months
Secondary Change scores of Brief Psychiatric Rating Scale Participants will complete the Brief Psychiatric Rating Scale (BPRS). It is total of 16 questions in this scale to evaluate psychiatric symptom. Each question is scored from 0-6 points.The higher scores mean a worse outcome. 9 months
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