Condition or disease | Intervention/treatment |
---|---|
Schizophrenia | Drug: Paliperidone Palmitate 3-Month Formulation (PP3M) |
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 |
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
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
|
||||
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 |
225 | ||||
Original Estimated Enrollment |
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:
Exclusion Criteria:
|
||||
Sex/Gender |
|
||||
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 |
|
||||
IPD Sharing Statement |
|
||||
Responsible Party | Janssen-Cilag International NV | ||||
Study Sponsor | Janssen-Cilag International NV | ||||
Collaborators | Not Provided | ||||
Investigators |
|
||||
PRS Account | Janssen-Cilag International NV | ||||
Verification Date | July 2019 |