Improving medication adherence with Treatment Adherence Therapy in patients with Schizophrenia.

Improving medication adherence with Treatment Adherence Therapy in patients with Schizophrenia. - Medication adherence in patients with Schizophrenia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37335

Enrollment

150

Registered

2012-10-09

Start date

2012-06-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psychotic disorder

Interventions

Treatment Adherence Therapy (TAT) has recently been developed by Prof Dr Niels Mulder en Dr Tonnie Staring (Erasmus Universiteit, Rotterdam). TAT consists of three main therapeutical modules, based

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1). diagnosis 'schizophrenia' according DSM-IV criteria 2). current presciption for antipsychotic medication 3). expected to stay on antipsychotic medication for the next 12 months. 4). outpatient and autonomous in collecting and using antipsychotic medication 5). poor medication adherence, defined as using

Exclusion criteria

Exclusion criteria: 1). Unable to follow TAT due to inadequate mastery of the Dutch language, or severe cognitive impairment. 2). severe substance abuse

Design outcomes

Primary

Measure	Time frame
Assessment of main and secondary study parameters will be conducted at baseline, 12 and 24 months after randomization. The time patients spent each assessment is approximately 55 minutes. The primary outcome measure is the proportion of non-adherent patients based on the Brief Adherence Rating Scale (BARS). The BARS is a brief clinician-administered adherence assessment (Byerly et al, 2008). The BARS evaluates episodes of missed medication taking in the past month. The score on the BARS represents the proportion of the taken doses to the prescribed doses. Based on a cut-off score of 80% of prescribed medication, patients will be labelled adherent or non-adherent. This is the most frequent used cut-off criterion in adherence studies for patients with schizophrenia (Valenstein et al., 2002).	—

Measure

Time frame

Assessment of main and secondary study parameters will be conducted at baseline, 12 and 24 months after randomization. The time patients spent each assessment is approximately 55 minutes. The primary outcome measure is the proportion of non-adherent patients based on the Brief Adherence Rating Scale (BARS). The BARS is a brief clinician-administered adherence assessment (Byerly et al, 2008). The BARS evaluates episodes of missed medication taking in the past month. The score on the BARS represents the proportion of the taken doses to the prescribed doses. Based on a cut-off score of 80% of prescribed medication, patients will be labelled adherent or non-adherent. This is the most frequent used cut-off criterion in adherence studies for patients with schizophrenia (Valenstein et al., 2002).

—

Secondary

Measure	Time frame
The following secondary outcome measures will be used to examine secondary clinical effects of TAT, moderators of effect, and costs of health care and work absence; The following secondary outcome measures will be used to examine secondary clinical effects of TAT, moderators of effect; 1. Re-hospitalization and drop out, based on case files 2. Quality of life, as measured with the Manchester Short Assessment of quality of life (MANSA), 3. Functioning, as measured with the Global Assessment of Functioning (GAF), and the Personal and Social Performance Scale (PSP) 4. Therapeutical alliance, as measured with the Helping Assessment Questionnaire (HAQ), 5. Psychopathology, as measured with the 'Brief Psychiatric Rating Scale' (BPRS-E), 6. Insight as measured with the Birchwood Scale, 7. Clients satisfaction with treatment and with medication as measured with the Treatment Perceptions Questionnaire (TPQ), the Client Satisfaction Questionnaire (CSQ), and the Treatment Satisfaction Questionnaire for Medication (TSQM), 8. Clients readiness to change as measured with the Readiness to Change Questionnaire (RTCQ), 9. Attitudes towards medication as measured with the Drug Attitude Inventory (DAI).	—

Measure

Time frame

The following secondary outcome measures will be used to examine secondary clinical effects of TAT, moderators of effect, and costs of health care and work absence; The following secondary outcome measures will be used to examine secondary clinical effects of TAT, moderators of effect; 1. Re-hospitalization and drop out, based on case files 2. Quality of life, as measured with the *Manchester Short Assessment of quality of life* (MANSA), 3. Functioning, as measured with the *Global Assessment of Functioning* (GAF), and the Personal and Social Performance Scale (PSP) 4. Therapeutical alliance, as measured with the *Helping Assessment Questionnaire* (HAQ), 5. Psychopathology, as measured with the 'Brief Psychiatric Rating Scale' (BPRS-E), 6. Insight as measured with the *Birchwood Scale*, 7. Clients satisfaction with treatment and with medication as measured with the *Treatment Perceptions Questionnaire* (TPQ), the *Client Satisfaction Questionnaire* (CSQ), and the *Treatment Satisfaction Questionnaire for Medication* (TSQM), 8. Clients readiness to change as measured with the *Readiness to Change Questionnaire* (RTCQ), 9. Attitudes towards medication as measured with the *Drug Attitude Inventory* (DAI).

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)