|- candidate number||24660|
|- NTR Number||NTR5973|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-jul-2016|
|- Secondary IDs||843002709 ZonMw|
|- Public Title||Evaluation of a rehabilitation group intervention in patients with persistent depressive disorder and their partner.|
|- Scientific Title||Economic evaluation of psychiatric rehabilitation/self-management group intervention (PPEP4All: Patient and Partner Education program for All chronic diseases)compared with usual care in patients with persistent depressive disorder and their partner; a multicenter pragmatic randomized controlled trial.|
|- hypothesis||Compared to usual care, PPEP4All will cost less, lead to better quality of life, fewer psychological symptoms, more resilience, and less chronic disease burden for both patient and partner.|
|- Healt Condition(s) or Problem(s) studied||Depressive Disorder , Chronic|
|- Inclusion criteria||Patients > 18 years with primary diagnosis Persistent Depressive Disorder.|
|- Exclusion criteria||Severe psychiatric (co)morbidity (e.g. substance abuse, suicidality, psychotic) and/or severe somatic comorbidty; cognitive problems; insufficient Dutch language proficiency. |
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||30-dec-2016|
|- planned closingdate||30-dec-2020|
|- Target number of participants||514|
|- Interventions||PPEP4All (Patient and Partner Education program for All chronic diseases) compared with usual care. |
|- Primary outcome||Quality of life (QALYs).|
|- Secondary outcome||Costs, psychopathology, resilience, disease burden.|
|- Timepoints||T1 baseline; T2 post-treatment at 3 months; T3 follow-up 1 at 6 months; T4 follow-up 2 at 12 months.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr. I.V.E. Carlier|
|- CONTACT for SCIENTIFIC QUERIES||Dr. I.V.E. Carlier|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Department of Psychiatry|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||OBJECTIVES/RESEARCH QUESTION: What are costs and effects of group-oriented Psychiatrie Rehabilitation ("Patient and Partner Education Program for All chronic diseases": PPEP4AII) in patients with Persistent Depressive Disorder (PDD) and their partner (or significant other), compared to Usual care?|
HYPOTHESIS: Compared to Usual care, PPEP4AII will cost less, lead to better quality of life, fewer psychological symptoms, more resilience, less chronic disease burden.
STUDY DESIGN: Multicentre Pragmatic Randomised Controlled Trial (superiority design).
STUDY POPULATION: PatiŽnts with PDD (chronic depressed >2 yr), > 18 yr, with their partner/significant other.
INTERVENTION: PPEP4AII (www.ppep4all.nl) with 9 weekly group sessions Rehabilitation and separate partner group.
USUAL CARE: Pharmaco- and/or psychotherapy and psychiatrie nurse guidance.
OUTCOME MEASURES: Primary is quality of life (QALYs); Secondary are costs, psychopathology, resilience, disease burden.
SAMPLE SIZE CALCULATION & DATA ANALYSIS: Based upon power (.85) and alpha (.05), 514 patients are needed (including 10% attrition): 2x257 (PPEP4AII vs Usual care). Primary data analysis: T-test for quality of life using EQ-5D-5L results and cost-effectiveness analysis (at 1 yr). Secondary data analysis: all secondary parameters (weighted generalized estimating equation analyses) and Budget Impact Analysis. All analyses according to intention-to-treat principle; and subgroup analyses for age, gender, ethnicity.
COST-EFFECTIVENESS ANALYSIS (CEA) & BUDGET IMPACT ANALYSIS (BIA): Economic evaluation (CEA) will consist of cost-utility analysis from societal perspective with time horizon of 1 yr. Health care use, patient cost/expenditure, and absence from work will be assessed. Differences in mean costs and effects between strategies will be compared with two-sided bootstrapping. In a net-benefit analysis, costs will be related to patient reported outcomes. In the BIA, the consequences of different scenarios with regard to the extent of implementation of PPEP4AII will be assessed from several perspectives (societal, public purse, health insurer, health care provider).
TIME SCHEDULE: total of 48 mths. Start-up 3 mnths (1-3); lnclusion/assessments/data entry 30 mnths (4-33); Analysis/publications 15 mnths (34-48).
|- Main changes (audit trail)|
|- RECORD||20-jul-2016 - 7-sep-2016|