SchizophreniaNCT05304780
Needs-tailored Nurse-led Recovery Program for Community-dwelling People With Schizophrenia
A study testing needs-tailored nurse-led recovery program in people with Schizophrenia and Recovery, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Schizophrenia, Recovery, Medication Adherence
- What is being tested?
- needs-tailored nurse-led recovery program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jul 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taipei University of Nursing and Health Sciences
Taipei, 112303
About this study
Official title: Effectiveness of a Needs-tailored Nurse-led Recovery Program for Community-dwelling People With Schizophrenia: A Cluster-randomized Controlled Trial
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.
Read the 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.
- Conditions
- Schizophrenia, Recovery, Medication Adherence
- Being tested
- needs-tailored nurse-led recovery program
- Keywords
- Needs-tailored, Recovery, Empowerment, Hope, Medication Adherence, Cluster-randomized controlled trial
- Medical subject headings
- Schizophrenia, Medication Adherence, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
needs-tailored nurse-led recovery programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Needs-tailored nurse-led recovery program Receives: Behavioral: needs-tailored nurse-led recovery program |
| Control group | No intervention | existing community homecare services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 9 months
Secondary outcomes (15)
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.
Measured: baseline
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.
Measured: 6 months
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.
Measured: 9 months
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.
Measured: baseline
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.
Measured: 6 months
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.
Measured: 9 months
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.
Measured: baseline
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.
Measured: 6 months
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.
Measured: 9 months
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.
Measured: baseline
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.
Measured: 6 months
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.
Measured: 9 months
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.
Measured: baseline
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.
Measured: 6 months
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start15 Jul 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council
- Responsible party
- Principal investigator, Wen I Liu, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304780
- Sponsor's protocol ID
- needs-tailored
- Status last verified
- Jan 2024
- First submitted
- 3 Mar 2022
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38755582
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Needs-tailored Nurse-led Recovery Program for Community-dwelling People With Schizophrenia: A Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05304780
- Acronym / sponsor ID
- needs-tailored
- Conditions
- Schizophrenia, Recovery, Medication Adherence
- Keywords
- Needs-tailored, Recovery, Empowerment, Hope, Medication Adherence, Cluster-randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- National Science and Technology Council
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: needs-tailored nurse-led recovery programNeeds-tailored nurse-led recovery program |
| Control group | No intervention | –existing community homecare services |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| needs-tailored nurse-led recovery programThe 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. | Behavioural | experimental group |
Primary outcome
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.
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.
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.
15 secondary outcomes
Change scores of Rogers Empowerment Scale
Time frame: baseline
Change scores of Rogers Empowerment Scale
Time frame: 6 months
Change scores of Rogers Empowerment Scale
Time frame: 9 months
Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness
Time frame: baseline
Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness
Time frame: 6 months
Change scores of Needs Assessment Instrument for the Community-Dwelling People with Mental Illness
Time frame: 9 months
Change scores of Herth Hope Index
Time frame: baseline
Change scores of Herth Hope Index
Time frame: 6 months
Change scores of Herth Hope Index
Time frame: 9 months
Change scores of Medication Adherence Rating Scale
Time frame: baseline
Change scores of Medication Adherence Rating Scale
Time frame: 6 months
Change scores of Medication Adherence Rating Scale
Time frame: 9 months
Change scores of Brief Psychiatric Rating Scale
Time frame: baseline
Change scores of Brief Psychiatric Rating Scale
Time frame: 6 months
Change scores of Brief Psychiatric Rating Scale
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Derived from this study: PubMed 38755582Liu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing needs-tailored nurse-led recovery program in people with Schizophrenia and Recovery, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change scores of Questionnaire about the Process of Recovery (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05304780, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.