Brief Intervention for Sleep Medication Misuse Among Elderly (BI-sleep)

University Hospital, Akershus

Status: Enrolling

Conditions: Harmful Use of Hypnotic

Treatments: Behavioral: BI (Brief Intervention)

Study type: Interventional

Funder types: Other

Identifiers

NCT06032715

BI-sleep

Details and patient eligibility

About

Randomized controlled trial to evaluate effectiveness of behavioral Brief Intervention administered by General practitioners (GPs) versus business as usual on use of Z-hypnotics by elderly patients in primary care.

Full description

Two armed study with controlled masked first part over 6 months. Active arm is with Brief Intervention for inappropriate use of Z-hypnotics among elderly with intervention delivered by trained GPs. Control arm is for patients handled by their (non-trained) GPs with business as usual (BAU). Main outcome is 6 weeks after intervention with additional data collection points after 6 months (blinded) and long-term follow-up to 12 months (open). After 6 months there will be an open single crossover as BAU GPs will then also receive training in the Brief Intervention method.

Baseline assessments are limited to self reports and automatic sleep assessment with actigraphy to avoid assessment effects. Follow-up at main outcome time point is in person, some outcomes are also by telephone assessment and compared to baseline prior to intervention (e g Actigraphy assessment.

Enrollment: 120 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Self-reported use of Z-hypnotics > 4 days per week and > 4 weeks

Exclusion criteria

• diagnosis of dementia,
• diagnosis of psychosis,
• diagnosis of major depression,
• diagnosis of delirium,
• unable to give informed consent,
• insufficient Norwegian language capacity to complete tests

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

BI (Brief Intervention)

Active Comparator group

Description:

Patients whose GPs have been taught the behavioral BI intervention aiming to reduce prolonged use of Z-hypnotics.

Treatment:

Behavioral: BI (Brief Intervention)

BAU (Business as usual)

No Intervention group

Description:

Patients whose GPs have not yet been taught the BI intervention. Patients only assessed in parallel with BI group by masked assessors using same instruments as for active comparator. This group also constitutes an open cross-over group to active intervention once the masked 6 months phase is completed.