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

Not Applicable

Completed

• Conditions: Recovery; Medication Adherence; Schizophrenia
• Interventions: Behavioral: needs-tailored nurse-led recovery program

• Registration Number: NCT05304780
• Lead Sponsor: National Taipei University of Nursing and Health Sciences

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-07-15
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	needs-tailored nurse-led recovery program	Needs-tailored nurse-led recovery program

Primary Outcome Measures

Name	Time	Method
Change scores of Questionnaire about the Process of Recovery	9 months	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.

Secondary Outcome Measures

Name	Time	Method
Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness	9 months	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.
Change scores of Herth Hope Index	9 months	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.
Change scores of Brief Psychiatric Rating Scale	9 months	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.
Change scores of Medication Adherence Rating Scale	9 months	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.
Change scores of Rogers Empowerment Scale	9 months	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.

Trial Locations

Locations (1)

National Taipei University of Nursing and Health Sciences; 🇨🇳 Taipei City, Taiwan