Needs Tailored Recovery Program for Patients With Severe Mental Illness

Sponsor
National Taipei University of Nursing and Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05304780
Collaborator
Ministry of Science and Technology, Taiwan (Other)
300
1
2
27.5
10.9

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: smart e-care needs tailored recovery program (NTRP)
N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Needs Tailored Recovery Program for Community-Dwelling Patients With Severe Mental Illness II: Effectiveness and Development of a Smart Care Platform
Actual Study Start Date :
Jul 15, 2020
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: experimental group

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

Behavioral: smart e-care needs tailored recovery program (NTRP)
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.

No Intervention: Control group

Routine home care visit

Outcome Measures

Primary Outcome Measures

  1. Change scores of Questionnaire about the Process of Recovery [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 [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 [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 Outcome Measures

  1. Change scores of Rogers Empowerment Scale [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taipei University of Nursing and Health Sciences Taipei City Taiwan 112303

Sponsors and Collaborators

  • National Taipei University of Nursing and Health Sciences
  • Ministry of Science and Technology, Taiwan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wen I Liu, Professor, National Taipei University of Nursing and Health Sciences
ClinicalTrials.gov Identifier:
NCT05304780
Other Study ID Numbers:
  • needs-tailored
First Posted:
Mar 31, 2022
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wen I Liu, Professor, National Taipei University of Nursing and Health Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022