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出境医 / 临床实验 / A Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly

A Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly

Study Description
Brief Summary:
The purpose of this study is to explore the experience with paliperidone palmitate 3-month formulation (PP3M) treatment of participants and their corresponding physicians, nurses and carers, to understand the impact of less frequent injections from their perspective.

Condition or disease Intervention/treatment
Schizophrenia Drug: Paliperidone Palmitate 3-Month Formulation (PP3M)

Study Design
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Study Type : Observational
Actual Enrollment : 225 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cross-sectional Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly
Actual Study Start Date : November 21, 2018
Actual Primary Completion Date : July 12, 2019
Actual Study Completion Date : July 12, 2019
Arms and Interventions
Group/Cohort Intervention/treatment
Participants with Schizophrenia
No intervention will be administered as a part of this study. Participants diagnosed with schizophrenia, who have been treated with 4 to 6 injections of paliperidone palmitate 3-month formulation (PP3M), together with the corresponding physician, and the corresponding nurse and carer where applicable for each participant will be enrolled in this survey. The data source for this study will be the online questionnaire used for each participant, physician, and the corresponding nurse and carer where applicable.
Drug: Paliperidone Palmitate 3-Month Formulation (PP3M)
No intervention will be administered as a part of this study. Participants who have been treated with PP3M in clinical practice will be enrolled.
Other Name: Trevicta

Outcome Measures
Primary Outcome Measures :
  1. Participant's Experience with PP3M Treatment [ Time Frame: 1 day ]
    Participant's experience with paliperidone palmitate 3-month formulation (PP3M) treatment will be evaluated qualitatively through an online questionnaire. Each questionnaire will include a total of approximately 30 to 35 multiple choice questions related to following categories: Impact on relationship/ interaction between medical team and carer/ patient, Involvement in treatment decision, Reasons for PP3M, Impact of treatment on patient, Impact of treatment on carer and General experience with PP3M.


Secondary Outcome Measures :
  1. Responses to the Questionnaires [ Time Frame: 1 day ]
    The response to the questionnaires of the corresponding physician, and the corresponding nurse and carer where applicable, for each participant will be collected for the following categories: Impact on relationship/ interaction between medical team and carer/ patient, Involvement in treatment decision, Reasons for PP3M, Impact of treatment on patient, Impact of treatment on carer and General experience with PP3M.

  2. Clinical Global Impression-Severity (CGI-S) Score [ Time Frame: 1 day ]
    The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. The CGI-S permits a global evaluation of the participant's condition at a given time.

  3. Positive and Negative Syndrome Scale (PANSS) - Lack of Judgement and Insight's Score (G12 Item) [ Time Frame: 1 day ]
    The PANSS is a validated scale specific for the measurement of the symptoms of schizophrenia. The neuropsychiatric symptoms of schizophrenia are assessed across 3 subscales comprising a total of 30 items; the positive [P] and negative [N] subscales each includes 7 items, while the general psychopathology [G] subscale includes 16 items. Lack of judgment and insight's score is 12th item of the general psychopathology subscale (G12 item) of PANSS with score ranges from 1 to 7. Higher scores indicate worsening.

  4. European Quality of Life (EuroQol) 5-Dimension 5-Level (EQ 5D-5L) Questionnaire General Health Status Score [ Time Frame: 1 day ]
    EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The responses to the 5 dimensions are used to compute a single utility score ranging from zero (worst health state) to 1 (better health state) representing the general health status of the individual.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants diagnosed with schizophrenia who are currently receiving paliperidone palmitate 3-month formulation (PP3M) and have previously received 4 to 6 injections of PP3M treatment will be enrolled. Feedback will be collected using an online questionnaire-based tool at a single data collection time point.
Criteria

Inclusion Criteria:

  • Have a diagnosis of schizophrenia (according to International Classification of Diseases [ICD]-10)
  • Be currently receiving PP3M and have previously received 4 to 6 injections of PP3M
  • Have the required language skills to participate in the online questionnaire, in the opinion of the physician
  • Be able and willing to provide their informed consent for study participation

Exclusion Criteria:

  • Has received involuntary treatment with PP3M
  • Was switched to PP3M treatment within a clinical trial
Contacts and Locations

Locations
Show Show 41 study locations
Sponsors and Collaborators
Janssen-Cilag International NV
Investigators
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Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
Tracking Information
First Submitted Date January 17, 2019
First Posted Date January 18, 2019
Last Update Posted Date August 1, 2019
Actual Study Start Date November 21, 2018
Actual Primary Completion Date July 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 17, 2019)
Participant's Experience with PP3M Treatment [ Time Frame: 1 day ]
Participant's experience with paliperidone palmitate 3-month formulation (PP3M) treatment will be evaluated qualitatively through an online questionnaire. Each questionnaire will include a total of approximately 30 to 35 multiple choice questions related to following categories: Impact on relationship/ interaction between medical team and carer/ patient, Involvement in treatment decision, Reasons for PP3M, Impact of treatment on patient, Impact of treatment on carer and General experience with PP3M.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 17, 2019)
  • Responses to the Questionnaires [ Time Frame: 1 day ]
    The response to the questionnaires of the corresponding physician, and the corresponding nurse and carer where applicable, for each participant will be collected for the following categories: Impact on relationship/ interaction between medical team and carer/ patient, Involvement in treatment decision, Reasons for PP3M, Impact of treatment on patient, Impact of treatment on carer and General experience with PP3M.
  • Clinical Global Impression-Severity (CGI-S) Score [ Time Frame: 1 day ]
    The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. The CGI-S permits a global evaluation of the participant's condition at a given time.
  • Positive and Negative Syndrome Scale (PANSS) - Lack of Judgement and Insight's Score (G12 Item) [ Time Frame: 1 day ]
    The PANSS is a validated scale specific for the measurement of the symptoms of schizophrenia. The neuropsychiatric symptoms of schizophrenia are assessed across 3 subscales comprising a total of 30 items; the positive [P] and negative [N] subscales each includes 7 items, while the general psychopathology [G] subscale includes 16 items. Lack of judgment and insight's score is 12th item of the general psychopathology subscale (G12 item) of PANSS with score ranges from 1 to 7. Higher scores indicate worsening.
  • European Quality of Life (EuroQol) 5-Dimension 5-Level (EQ 5D-5L) Questionnaire General Health Status Score [ Time Frame: 1 day ]
    EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The responses to the 5 dimensions are used to compute a single utility score ranging from zero (worst health state) to 1 (better health state) representing the general health status of the individual.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly
Official Title Cross-sectional Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly
Brief Summary The purpose of this study is to explore the experience with paliperidone palmitate 3-month formulation (PP3M) treatment of participants and their corresponding physicians, nurses and carers, to understand the impact of less frequent injections from their perspective.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants diagnosed with schizophrenia who are currently receiving paliperidone palmitate 3-month formulation (PP3M) and have previously received 4 to 6 injections of PP3M treatment will be enrolled. Feedback will be collected using an online questionnaire-based tool at a single data collection time point.
Condition Schizophrenia
Intervention Drug: Paliperidone Palmitate 3-Month Formulation (PP3M)
No intervention will be administered as a part of this study. Participants who have been treated with PP3M in clinical practice will be enrolled.
Other Name: Trevicta
Study Groups/Cohorts Participants with Schizophrenia
No intervention will be administered as a part of this study. Participants diagnosed with schizophrenia, who have been treated with 4 to 6 injections of paliperidone palmitate 3-month formulation (PP3M), together with the corresponding physician, and the corresponding nurse and carer where applicable for each participant will be enrolled in this survey. The data source for this study will be the online questionnaire used for each participant, physician, and the corresponding nurse and carer where applicable.
Intervention: Drug: Paliperidone Palmitate 3-Month Formulation (PP3M)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 31, 2019)
225
Original Estimated Enrollment
 (submitted: January 17, 2019)
300
Actual Study Completion Date July 12, 2019
Actual Primary Completion Date July 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Have a diagnosis of schizophrenia (according to International Classification of Diseases [ICD]-10)
  • Be currently receiving PP3M and have previously received 4 to 6 injections of PP3M
  • Have the required language skills to participate in the online questionnaire, in the opinion of the physician
  • Be able and willing to provide their informed consent for study participation

Exclusion Criteria:

  • Has received involuntary treatment with PP3M
  • Was switched to PP3M treatment within a clinical trial
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   France,   Germany,   Hungary,   Italy,   Spain,   United Kingdom
Removed Location Countries Ireland
 
Administrative Information
NCT Number NCT03809325
Other Study ID Numbers CR108568
R092670SCH4066 ( Other Identifier: Janssen-Cilag International NV )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Janssen-Cilag International NV
Study Sponsor Janssen-Cilag International NV
Collaborators Not Provided
Investigators
Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
PRS Account Janssen-Cilag International NV
Verification Date July 2019