NCT05304780

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

1.5 years

First QC Date

March 3, 2022

Last Update Submit

January 4, 2024

Conditions

SchizophreniaRecoveryMedication Adherence

Keywords

Needs-tailoredRecoveryEmpowermentHopeMedication AdherenceCluster-randomized controlled trial

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (15)

  • Change scores of Rogers Empowerment Scale

    baseline

  • Change scores of Rogers Empowerment Scale

    6 months

  • Change scores of Rogers Empowerment Scale

    9 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

  • +10 more secondary outcomes

Study Arms (2)

experimental group

EXPERIMENTAL

Needs-tailored nurse-led recovery program

Behavioral: needs-tailored nurse-led recovery program

Control group

NO INTERVENTION

existing community homecare services

Interventions

needs-tailored nurse-led recovery programBEHAVIORAL

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.

experimental group

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taipei University of Nursing and Health Sciences

Taipei, 112303, Taiwan

Location

Related Publications (1)

  • Liu WI, Hsieh WL, Lai CT, Liu CC, Tai YM, Liu CY. Effectiveness of a needs-tailored nurse-led recovery program for community-dwelling people with schizophrenia: a cluster-randomized controlled trial. BMC Nurs. 2024 May 16;23(1):329. doi: 10.1186/s12912-024-01986-x.

    PMID: 38755582DERIVED

MeSH Terms

Conditions

SchizophreniaMedication AdherenceEmpowerment

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorSocial Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 3, 2022

First Posted

March 31, 2022

Study Start

July 15, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 8, 2024

Record last verified: 2024-01

Locations

TW(1)