Brief Intervention for Sleep Medication Misuse Among Elderly

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Brief Intervention for Reducing Prolonged Use of Sleep Medication Among Elderly

Conditions
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Harmful Use of Hypnotic

Intervention / Treatment
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* Behavioral: BI (Brief Intervention)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel masked and controlled first part intervention vs Business as usual with follow-up after 6 months by masked assessors. Subsequently open single cross-over of business as usual patients to also receive the same intervention.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BI (Brief Intervention)<br>Patients whose GPs have been taught the behavioral BI intervention aiming to reduce prolonged use of Z-hypnotics. | Behavioral: BI (Brief Intervention)<br>* Short structured individual behavioral intervention to reduce inappropriate usage of Z-hypnotics<br>|
| No Intervention: BAU (Business as usual)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inappropriate Z-hypnotics use | Proportion of patients with prolonged use of Z-hypnotics | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain visual analogue scale (VAS) | VAS assessment of experienced pain (1-100 mm, no pain (0), worst possible pain (100)) | 6 weeks | 
| Cognitive function | Cognistat test total score (0-84, 84 best) | 6 weeks | 
| Cognitive function | Cognistat test total score (0-84, 84 best) | 6 months | 
| Experience of sleep | Global Sleep Assessment Questionnaire score (GSAQ) (11 items, Never, sometimes, usually, always. Item responses were converted to a common 0-100 scale, with a higher score indicating greater likelihood for presence of the disorder. .) | 6 weeks | 
| Experience of sleep | Global Sleep Assessment Questionnaire score (GSAQ) (11 items, Never, sometimes, usually, always. Item responses were converted to a common 0-100 scale, with a higher score indicating greater likelihood for presence of the disorder. .) | 6 months | 
| Sleep efficiency (random subpopulation) | Actigraphy assessed before and after intervention | 6 weeks | 
| Change compared to baseline of Z-hypnotics use | Proportion of patients with prolonged use of Z-hypnotics | 6 weeks | 
| Change compared to baseline of Z-hypnotics use | Proportion of patients with prolonged use of Z-hypnotics | 6 months | 
| Inappropriate Z-hypnotics use | Proportion of patients with prolonged use of Z-hypnotics | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Z-hypnotics, insomnia, sleep, side effects, cognitive function, pain, behavioral intervention, dependence, quality of life