Harmful Use of Hypnotic
Conditions
Keywords
Z-hypnotics, insomnia, sleep, side effects, cognitive function, pain, behavioral intervention, dependence, quality of life
Brief summary
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
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.
Interventions
BEHAVIORALBI (Brief Intervention)
Short structured individual behavioral intervention to reduce inappropriate usage of Z-hypnotics
Sponsors
University of Oslo
University Hospital, Akershus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
GPs will be cluster randomized based on GP to two sequential teaching programs to learn the Brief Intervention procedure. The patients of those who have the course first will constitute the intervention arm while patients of GPs who are in the second course will constitute parallel business as usual controls in the masked part of the study. When the second group of GPs have their course, open cross-over will be possible.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inappropriate Z-hypnotics use | 6 weeks | Proportion of patients with prolonged use of Z-hypnotics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain visual analogue scale (VAS) | 6 weeks | VAS assessment of experienced pain (1-100 mm, no pain (0), worst possible pain (100)) |
| Cognitive function | 6 weeks | Cognistat test total score (0-84, 84 best) |
| Inappropriate Z-hypnotics use | baseline | Proportion of patients with prolonged use of Z-hypnotics |
| Sleep efficiency (random subpopulation) | 6 weeks | Actigraphy assessed before and after intervention |
| Change compared to baseline of Z-hypnotics use | 6 weeks | Proportion of patients with prolonged use of Z-hypnotics |
| Experience of sleep | 6 weeks | 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. .) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Verbal fluency | 6 weeks | FAS score (60 seconds timecap, using a cut-off score of 14 points indicating executive function deficits) |
| Multimorbidity | 6 weeks | Cumulative Illness Rating Scale-Geriatric (CIRS-G) 0-56, 56 worst |
| Polypharmacy | 6 weeks | Number of regularly used medications |
| Readiness to change behaviour | Baseline | Readiness to change behavior visual analogue scale scale, 0-100, 100 most ready |
| Prevalence of inappropriate medication use in screened population | At screening before baseline | Patient self report in screening questionnaire |
| Prevalence self-reported sleep difficulties | At screening before baseline | Patient self report in screening questionnaire |
| Change compared to baseline of Z-hypnotics use | 12 months | Proportion of patients with prolonged use of Z-hypnotics |
| Mortality | 12 months, 24 months | Based on automatic registration in electronic patient journal |
| Cognitive function, subdimensions | 6 weeks | Cognistat test, subdimensions score, higher score is better cognitive function |
| Inappropriate Z-hypnotics use | 6 months | Proportion of patients with prolonged use of Z-hypnotics |
| Pain visual analogue scale (VAS) | 12 months | VAS assessment of experienced pain (1-100 mm, no pain (0), worst possible pain (100)) |
| Cognitive function | 12 months | Cognistat test total score (0-84, 84 best) |
| Anxiety and depression symptoms | 6 weeks | Hospital anxiety and depression scale (HADS), 0-42, 42 worst |
| Experience of sleep | 12 months | 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. .) |
| Quality of life measure, index | 6 months | Euro QoL, five dimension, 5 level version (EQ-5D-5L index, Norwegian population norms valuation), 0-1 with 1 representing perfect health |
| Quality of life measure, VAS | 6 months | Euro QoL, five dimension, 5 level version (EQ-5D VAS), 0-100 with 100 representing best health |
| Dependence score | 6 weeks | Severity of dependence score (SDS), 0-15, 15 highest severity |
| MoCa score | 6 weeks | Telefon - Montreal Cognitive Assessment (T-MoCA) for remote assessments. (0-22 points, normal cognition ≥ 18 / 22) |
| Self assessed cognitive function | 6 weeks | Norwegian cognitive function instrument (KFI) (0-13 points yes=1 point, maybe=0,5 point, no=0 point) |
Countries
Norway
Contacts
Primary ContactTahreem G Siddiqui, PhD
Outcome results
None listed