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Completed

NCT Number: NCT05304780

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

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.

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Key information

Conditions

Schizophrenia Behavior Empowerment Health Behavior Medication Adherence Mental Disorders Patient Acceptance of Health Care Patient Compliance Recovery Schizophrenia Spectrum and Other Psychotic Disorders Social Behavior Treatment Adherence and Compliance

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taipei University of Nursing and Health Sciences

Taipei, 112303, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

needs-tailored nurse-led recovery program

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Change scores of Rogers Empowerment Scale

    Time frame: baseline

    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.

  2. Change scores of Rogers Empowerment Scale

    Time frame: 6 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.

  3. Change scores of Rogers Empowerment Scale

    Time frame: 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.

  4. Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness

    Time frame: baseline

    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.

  5. Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness

    Time frame: 6 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.

  6. Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness

    Time frame: 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.

  7. Change scores of Herth Hope Index

    Time frame: baseline

    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.

  8. Change scores of Herth Hope Index

    Time frame: 6 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.

  9. Change scores of Herth Hope Index

    Time frame: 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.

  10. Change scores of Medication Adherence Rating Scale

    Time frame: baseline

    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.

  11. Change scores of Medication Adherence Rating Scale

    Time frame: 6 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.

  12. Change scores of Medication Adherence Rating Scale

    Time frame: 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.

  13. Change scores of Brief Psychiatric Rating Scale

    Time frame: baseline

    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.

  14. Change scores of Brief Psychiatric Rating Scale

    Time frame: 6 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.

  15. Change scores of Brief Psychiatric Rating Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Collaborators

  • National Science and Technology Council

Registry information

Official study title

Effectiveness of a Needs-tailored Nurse-led Recovery Program for Community-dwelling People With Schizophrenia: A Cluster-randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 31, 2022
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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