Effectiveness of a Needs-tailored Nurse-led Recovery Program for Community-dwelling People With Schizophrenia: A Cluster-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Change scores of Questionnaire about the Process of Recovery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control group
existing community homecare services
experimental group
Needs-tailored nurse-led recovery program
干预措施: needs-tailored nurse-led recovery program (Behavioral)
结局指标
主要结局
Change scores of Questionnaire about the Process of Recovery
时间窗: 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.
Change scores of Questionnaire about the Process of Recovery
时间窗: baseline
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.
Change scores of Questionnaire about the Process of Recovery
时间窗: 6 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.
次要结局
- Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness(9 months)
- Change scores of Herth Hope Index(9 months)
- Change scores of Brief Psychiatric Rating Scale(9 months)
- Change scores of Medication Adherence Rating Scale(9 months)
- Change scores of Rogers Empowerment Scale(9 months)
- Change scores of Rogers Empowerment Scale(baseline)
- Change scores of Rogers Empowerment Scale(6 months)
- Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness(baseline)
- Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness(6 months)
- Change scores of Herth Hope Index(baseline)
- Change scores of Herth Hope Index(6 months)
- Change scores of Medication Adherence Rating Scale(baseline)
- Change scores of Medication Adherence Rating Scale(6 months)
- Change scores of Brief Psychiatric Rating Scale(baseline)
- Change scores of Brief Psychiatric Rating Scale(6 months)
研究者
Wen I Liu
Professor
National Taipei University of Nursing and Health Sciences