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The effect of a discontinuation protocol on the use of clonazepam in the elderly

Effectiveness of a protocol for the deprescription of clonazepam use in the elderly: single-arm intervention trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-524ys9
Enrollment
Unknown
Registered
2019-06-11
Start date
2019-09-30
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Aged

Interventions

There will be 5 face-to-face meetings, every 14 days, with tests validated in Brazil or semi-structured (based on the literature), with 60 patients in all. Metting 1: a) Brief explanation of clonazep
c) medical anamnesis
d) Delivery of the Sleep Hygiene and Cartilage Primer Gradual reduction of clonazepam, both validated (by the Delphi technique) by the Clinical Pharmacy League of the Federal University of São João de
III-Pittsburg Sleep Quality Index -BR Decrease of 25% of the daily dose of clonazepam, taking 75% of the initial dose of clonazepam. Metting 2: I-PSQI-BR II-Signs and symptoms based on literature III
II-Signs and symptoms based on literature
III-Sociodemographic and clinical questionnaire, semi-structured
Decrease of 25% of the daily dose of clonazepam, taking 25% of the initial dose of clonazepam. Meeting 4: I-PSQI-BR
II-Signs and symptoms based on literature Clonazepam dose stop. Meeting 5 (final evaluation) I - WHOQOL-BREF
II - Instrument for the evaluation of falls validated in Brazil (IAQI)
III-Pittsburg Sleep Quality Index -BR
IV- Medical anamese. Addendum: a) Psychologists from the Health Units of the study will be at the disposal of patients in discretion, as well as the study pharmacy. b) In case of signs and symptoms o

Sponsors

Universidade Federal de São João del-Rei (UFSJ)
Lead Sponsor
Universidade Federal de São João del-Rei (UFSJ)
Collaborator

Eligibility

Age
60 Years to 100 Years

Inclusion criteria

Inclusion criteria: Elderly patients in clinical use of clonazepam will be included for anxiety and insomnia; administered daily for at least three months; which were attended at the Basic Health Units in question.

Exclusion criteria

Exclusion criteria: Epileptic patients will be excluded; patients in psychiatric treatment and / or with a history of psychosis; patients dependent on alcohol and illicit drugs; patients who are not cognitively competent and do not have a caregiver, according to the mini mental state examination; other unforeseen situations will be analyzed, in an individualized way, by the doctor of the health unit

Design outcomes

Primary

MeasureTime frame
The primary endpoint is to assess the proportion of elderly people who were able to reduce the dose of clonazepam or the total withdrawal of the drug as measured by the Clonazepam Deprescription Protocol in the elderly

Secondary

MeasureTime frame
To identify abstinence symptoms of clonazepam, as measured by the Benzodiazepine withdrawal symptom questionnaire;To verify if there was a change in quality of life before and after the depression, evaluated through the World Health Organization Quality of Life Group (WHOQOL-bref)

Countries

Brazil

Contacts

Public ContactComitê de Ética em Pesquisa cepes_cco_dona_lindu

Universidade Federal de São João del-Rei (UFSJ)

cepco@ufsj.edu.br+55 037 36904491

Outcome results

None listed

Source: REBEC (via WHO ICTRP)