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Money for Medication: A randomized controlled study on the effectiveness of financial incentives to improve medication adherence in patients with a psychotic disorder and co-morbid substance abuse.


- candidate number8108
- NTR NumberNTR2350
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-jun-2010
- Secondary IDsNL31406.097.10 CCMO
- Public TitleMoney for Medication: A randomized controlled study on the effectiveness of financial incentives to improve medication adherence in patients with a psychotic disorder and co-morbid substance abuse.
- Scientific TitleMoney for Medication: A randomized controlled study on the effectiveness of financial incentives to improve medication adherence in patients with a psychotic disorder and co-morbid substance abuse.
- ACRONYMMoney for Medication (M4M)
- hypothesisProviding M4M will increase patients acceptance of their prescribed antipsychotic depot medication.
- Healt Condition(s) or Problem(s) studiedAntipsychotics, Psychotic disorders, Substance abuse
- Inclusion criteria1. Age between 18 and 65 years;
2. Psychotic disorder (including schizophrenia, schizoaffective disorder or other psychotic disorders);
3. Substance use disorder (alcohol and/or drugs);
4. Indication for antipsychotic depot medication;
5. Outpatient treatment (either starting outpatient treatment or being in outpatient treatment for at least four months and having missed prescribed depot medications;
6. Given informed consent.
- Exclusion criteria1. Not meeting all inclusion criteria;
2. Inability to participate in this study due to cognitive impairments;
3. And/or an inability to understand the Dutch language sufficiently to participate in this study.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2010
- planned closingdate30-sep-2012
- Target number of participants168
- InterventionsPatients assigned to the intervention group (M4M) will receive treatment as usual, plus a financial incentive for each time they accept their prescribed depot of antipsychotic medication. All patients in the intervention group (M4M) will receive an average maximum of 30 euro per month. The amount of money they will receive is dependent upon the frequency of the depot. For example, a patient who receives a two-weekly depot will receive 15 euro per accepted depot. A patient who receives a three-weekly depot will receive 22.50 euro for each accepted depot etcetera.
- Primary outcomeThe number (percentage) of accepted depot injections.
- Secondary outcome1. Longest uninterrupted period of depot medication acceptance;
2. Time expired before depot is taken;
3. Effort initiated by clinicians to provide depot;
4. Psychiatric symptomatology (PANSS);
5. Health, psychological and social functioning (HoNOS);
6. Substance use (ASI, Section III, CIDI-SAM, verified by urine-analysis);
7. Subjective Quality of Life (MANSA);
8. Antipsychotic Side-effects (ASC);
9. Cost Utility (TiC-P, EQ-5D);
10. Impulsivity (DII);
11. Attitudes towards medication (ROMI);
12. Attitudes towards M4M.
- Timepoints1. Baseline (Month 0);
2. End of intervention (Month 12);
3. Follow-up (Month 18).
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Charlotte Audier
- CONTACT for SCIENTIFIC QUERIESProf. Dr. C.L. Mulder
- Sponsor/Initiator Centrum Dubbele Problematiek (CDP), Palier
- Funding
(Source(s) of Monetary or Material Support)
Palier, Centrum Dubbele Problematiek (CDP), The Hague, The Netherlands
- PublicationsN/A
- Brief summaryMoney for Medication (M4M) is a randomized controlled study on the effectivenes of financial incentives in improving adherence with antipsychotic depot medication in patients with psychotic disorders and co-morbid substance abuse.
- Main changes (audit trail)
- RECORD1-jun-2010 - 15-okt-2010


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