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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Enrollment
120
Short structured individual behavioral intervention to reduce inappropriate usage of Z-hypnotics
Akershus University Hospital
Lørenskog, Norway
RECRUITINGInappropriate Z-hypnotics use
Proportion of patients with prolonged use of Z-hypnotics
Time frame: 6 weeks
Pain visual analogue scale (VAS)
VAS assessment of experienced pain (1-100 mm, no pain (0), worst possible pain (100))
Time frame: 6 weeks
Cognitive function
Cognistat test total score (0-84, 84 best)
Time frame: 6 weeks
Cognitive function
Cognistat test total score (0-84, 84 best)
Time frame: 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. .)
Time frame: 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. .)
Time frame: 6 months
Sleep efficiency (random subpopulation)
Actigraphy assessed before and after intervention
Time frame: 6 weeks
Change compared to baseline of Z-hypnotics use
Proportion of patients with prolonged use of Z-hypnotics
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Time frame: 6 weeks
Change compared to baseline of Z-hypnotics use
Proportion of patients with prolonged use of Z-hypnotics
Time frame: 6 months
Inappropriate Z-hypnotics use
Proportion of patients with prolonged use of Z-hypnotics
Time frame: baseline