Evaluation of Drug Treatment Adherence of Patients With Mental Disorders.

• Register: REBEC
• Last refreshed on: 27 May 2013
• Main ID: RBR-445br3
• Date of registration: 23/04/2012
• Primary sponsor: Universidade Federal de Sergipe - Brazil
• Public title: Evaluation of Drug Treatment Adherence of Patients With Mental Disorders.
• Scientific title: Evaluation of Pharmacotherapy Adherence of Patients Attended to Pharmaceutical Service in a Psychosocial Care Center.
• Date of first enrolment: 01/01/2011
• Target sample size: 16
• Recruitment status: recruitment completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-445br3/
• Study type: Intervention
• Study design: Clinical trial, open, not randomized

Countries of recruitment

Brazil

Contacts

• Name: Wellington da Silva
• Affiliation: Universidade Federal de Sergipe

• Name: Juliana Rabelo
• Affiliation: Universidade Federal de Sergipe

Key inclusion & exclusion criteria

Inclusion criteria: Individuals over 18 years. Diagnosed with schizophrenia, schizotypal and delusional disorders. Which are in treatment for at least six months. For which pharmacotherapy was prescribed; Those who accepted participate in the study by signing a Statement of Informed Consent.
Exclusion criteria: Patients who are in crisis. Patients who have psychiatric symptom associated with a diagnosis inconclusive or not yet elucidated. Patients who have evidence or diagnosis of neurological or cognitive damage.

Age minimum: 18
Age maximum: 0
Gender: -

Health Condition(s) or Problem(s) studied

Adherence and knowledgement level about treatment with patients diagnosed with schizophrenia, schizotypal and delusional disorders.
Z86.5

G00-G99

Intervention(s)

The intervention procedure consists in carrying out clinical interviews, followed by the identification of drug-related problems and develop an individualized action plan about pharmacological treatment. The procedure is based on obtaining patient's pharmacotherapeutics history, as well as evaluation of needs and experiences of patients during the use of medication in order to identify and resolve possible drug-related problems presented by the patient, as proposed by the Dáder method (Machuca et al., 2002). After this identification, will be held pharmaceutical interventions necessary to resolve the drug-related problems and subsequently evaluate the results.

Primary Outcome(s)

Adherence to treatment and identification of drug influences. Haynes-Sackett test: consists in this question: "Most people have trouble taking pills, do you have some difficulty to take yours?" It is requested the average number of missed pills during a period of time (for example, in the last fortnight or last month). Good adherence can be characterized when the values are between 80% and 100%.
Morinsky-Green test: for this method, patients that have good adherence are those who respond adequately to these four questions: 1) "do you ever forget to take your medication?" 2) "do you take the drugs at the indicated time? "3)" when you are well, do you stop taking your medications? "4)" if you ever feel bad, do you stop taking your medications?". For drug influences evaluation is used the Rating of Medication Influences (ROMI).

Knowledgement level about the treatment/medication use. The level of user awareness about the treatment or use of drugs will be set according to the percentage of individuals who report correctly the indication, dosage and method of using the drug ("when and how to use your medication") (WHO, 1993).
Later, it will be used the formula: %CUM = X/Y x 100. Where: %CUM: percentage of knowledge about the medication use, Y: number of patients who respond correctly "when and how to use their medication" and X: total number of interviewed patients.

Secondary Outcome(s)

Drug-related problems. Drug-related problems is defined as negative clinical outcomes, derived from pharmacological treatment that has produced a number of causes as a consequence, does not reach the desired therapeutic goal or the appearance of undesirable effects.

Secondary ID(s)

1445.0.000.107-10

Source(s) of Monetary Support

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPES - Brazil

Secondary Sponsor(s)

Secretaria Municipal de Saúde de São Cristóvão - Brazil