Clinical trial NCT05304780: Needs-tailored Nurse-led Recovery Program for Community-dwelling People With Schizophrenia
Official title: Effectiveness of a Needs-tailored Nurse-led Recovery Program for Community-dwelling People With Schizophrenia: A Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Recovery
Medication Adherence
Keywords: Needs-tailored
Recovery
Empowerment
Hope
Medication Adherence
Cluster-randomized controlled trial
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council
First posted: 2022-03-31
Enrollment: 164
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change scores of Questionnaire about the Process of Recovery
timeFrame: baseline
measure: Change scores of Questionnaire about the Process of Recovery
timeFrame: 6 months
measure: Change scores of Questionnaire about the Process of Recovery
timeFrame: 9 months
Secondary outcomes:
measure: Change scores of Rogers Empowerment Scale
timeFrame: baseline
measure: Change scores of Rogers Empowerment Scale
timeFrame: 6 months
measure: Change scores of Rogers Empowerment Scale
timeFrame: 9 months
measure: Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness
timeFrame: baseline
measure: Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness
timeFrame: 6 months
measure: Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness
timeFrame: 9 months
measure: Change scores of Herth Hope Index
timeFrame: baseline
measure: Change scores of Herth Hope Index
timeFrame: 6 months
measure: Change scores of Herth Hope Index
timeFrame: 9 months
measure: Change scores of Medication Adherence Rating Scale
timeFrame: baseline
measure: Change scores of Medication Adherence Rating Scale
timeFrame: 6 months
measure: Change scores of Medication Adherence Rating Scale
timeFrame: 9 months
measure: Change scores of Brief Psychiatric Rating Scale
timeFrame: baseline
measure: Change scores of Brief Psychiatric Rating Scale
timeFrame: 6 months
measure: Change scores of Brief Psychiatric Rating Scale
timeFrame: 9 months
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taipei University of Nursing and Health Sciences
Study officials:
References: