Effectiveness of a Needs-tailored Nurse-led Recovery Program for Community-dwelling People With Schizophrenia: A Cluster-randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 164
- Locations
- 1
- Primary Endpoint
- Change scores of Questionnaire about the Process of Recovery
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control group
existing community homecare services
experimental group
Needs-tailored nurse-led recovery program
Intervention: needs-tailored nurse-led recovery program (Behavioral)
Outcomes
Primary Outcomes
Change scores of Questionnaire about the Process of Recovery
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Wen I Liu
Professor
National Taipei University of Nursing and Health Sciences