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Needs Tailored Recovery Program for Patients With Severe Mental Illness

Primary Purpose

Mental Illness, Schizophrenia, Recovery

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
smart e-care needs tailored recovery program (NTRP)
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mental Illness focused on measuring Community-dwelling people with mental illness, Needs-tailored, Recovery, Empowerment, Hope, Medication Adherence, Randomized controlled trial, Smart care platform

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • living in the community and diagnosed with a schizophrenia- or mood-related disorder
  • aged 20-64 years
  • able to communicate in Mandarin or Taiwanese
  • provided consent to participate in the study.

Exclusion Criteria:

  • living in a community institution such as a rehabilitation home, community rehabilitation, center, nursing home, or day hospital
  • organic psychotic disorders
  • drug or alcohol addiction

Sites / Locations

  • National Taipei University of Nursing and Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

Control group

Arm Description

smart e-care needs tailored recovery program (NTRP) platform

Routine home care visit

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Change scores of Rogers Empowerment Scale
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.
Change scores of Rogers Empowerment Scale
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.
Change scores of Rogers Empowerment Scale
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.
Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness
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.
Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness
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.
Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness
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.
Change scores of Herth Hope Index
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.
Change scores of Herth Hope Index
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.
Change scores of Herth Hope Index
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.
Change scores of Medication Adherence Rating Scale
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.
Change scores of Medication Adherence Rating Scale
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.
Change scores of Medication Adherence Rating Scale
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.
Change scores of Brief Psychiatric Rating Scale
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.
Change scores of Brief Psychiatric Rating Scale
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.
Change scores of Brief Psychiatric Rating Scale
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.

Full Information

First Posted
March 3, 2022
Last Updated
September 1, 2023
Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Ministry of Science and Technology, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05304780
Brief Title
Needs Tailored Recovery Program for Patients With Severe Mental Illness
Official Title
Needs Tailored Recovery Program for Community-Dwelling Patients With Severe Mental Illness II: Effectiveness and Development of a Smart Care Platform
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Ministry of Science and Technology, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to establish an innovative smart e-care needs tailored recovery program (NTRP) platform for the community-dwelling patients with severe mental illness, and then evaluate the effectness of e-care needs tailored recovery program (NTRP).
Detailed Description
Last year, investigators used the pilot study to test the needs tailored recovery program feasibility, acceptability and preliminary usefulness of the tailored recovery program (NTRP). Based on the findings of the pilot study, then used a randomized controlled trial conducted to evaluate the effectiveness of the NTRP in two psychiatric centers of northern Taiwan. The treatment group receive the needs assessment and then the NTRP by their home-care nurses over 6 months. The control group receive the usual community psychiatric care only. And these participants had been collected baseline data. Investigators will conduct to test 6 months (post- intervention immediately), and 9 months (3 months post-intervention). Outcome measures include recovery, empowerment, hope, health needs score, and psychiatric symptoms. Then, based on the evidence of need-trailed recovery program, this study main aim is innovative smart care technology will be adopted to establish the smart e-care NTRP through the standardized process of platform goal (targeted actions) setting, development (content and format) and verification, and then evaluate this innovative care platform using mixed research methods (experimental and qualitative study design).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Illness, Schizophrenia, Recovery
Keywords
Community-dwelling people with mental illness, Needs-tailored, Recovery, Empowerment, Hope, Medication Adherence, Randomized controlled trial, Smart care platform

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
smart e-care needs tailored recovery program (NTRP) platform
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Routine home care visit
Intervention Type
Behavioral
Intervention Name(s)
smart e-care needs tailored recovery program (NTRP)
Intervention Description
Smart care technology will be adopted to establish the smart e-care Needs-Tailored Nurse-Led Recovery Program (NTRP) through the standardized process of platform goal (targeted actions) setting, development (content and format) and verification. By the way, the contents of NTRP were divided into five major stages of care:1. Build partnerships; 2. Conduct integrated needs assessment; 3. Set needs-based recovery goals and provide empowerment-oriented measures; 4. Conduct continuous monitoring of goals. 5. Conduct effectiveness evaluation: treat recovery as the primary outcome measure and other elements (needs, empowerment, hope, and medication adherence) as secondary outcome measures.
Primary Outcome Measure Information:
Title
Change scores of Questionnaire about the Process of Recovery
Description
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.
Time Frame
baseline
Title
Change scores of Questionnaire about the Process of Recovery
Description
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.
Time Frame
6 months
Title
Change scores of Questionnaire about the Process of Recovery
Description
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.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Change scores of Rogers Empowerment Scale
Description
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.
Time Frame
baseline
Title
Change scores of Rogers Empowerment Scale
Description
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.
Time Frame
6 months
Title
Change scores of Rogers Empowerment Scale
Description
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.
Time Frame
9 months
Title
Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness
Description
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.
Time Frame
baseline
Title
Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness
Description
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.
Time Frame
6 months
Title
Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness
Description
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.
Time Frame
9 months
Title
Change scores of Herth Hope Index
Description
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.
Time Frame
baseline
Title
Change scores of Herth Hope Index
Description
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.
Time Frame
6 months
Title
Change scores of Herth Hope Index
Description
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.
Time Frame
9 months
Title
Change scores of Medication Adherence Rating Scale
Description
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.
Time Frame
baseline
Title
Change scores of Medication Adherence Rating Scale
Description
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.
Time Frame
6 months
Title
Change scores of Medication Adherence Rating Scale
Description
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.
Time Frame
9 months
Title
Change scores of Brief Psychiatric Rating Scale
Description
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.
Time Frame
baseline
Title
Change scores of Brief Psychiatric Rating Scale
Description
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.
Time Frame
6 months
Title
Change scores of Brief Psychiatric Rating Scale
Description
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.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: living in the community and diagnosed with a schizophrenia- or mood-related disorder aged 20-64 years able to communicate in Mandarin or Taiwanese provided consent to participate in the study. Exclusion Criteria: living in a community institution such as a rehabilitation home, community rehabilitation, center, nursing home, or day hospital organic psychotic disorders drug or alcohol addiction
Facility Information:
Facility Name
National Taipei University of Nursing and Health Sciences
City
Taipei City
ZIP/Postal Code
112303
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Needs Tailored Recovery Program for Patients With Severe Mental Illness

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