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| Name | Class |
|---|---|
| University of Oslo | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI (Brief Intervention) | Active Comparator | Patients whose GPs have been taught the behavioral BI intervention aiming to reduce prolonged use of Z-hypnotics. |
|
| BAU (Business as usual) | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI (Brief Intervention) | Behavioral | Short structured individual behavioral intervention to reduce inappropriate usage of Z-hypnotics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inappropriate Z-hypnotics use | Proportion of patients with prolonged use of Z-hypnotics | 6 weeks |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life measure, index | Euro QoL, five dimension, 5 level version (EQ-5D-5L index, Norwegian population norms valuation), 0-1 with 1 representing perfect health | 6 months |
| Quality of life measure, VAS |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tahreem G Siddiqui, PhD | Contact | 90600984 | +47 | tahs@ahus.no |
| Name | Affiliation | Role |
|---|---|---|
| Christofer Lundqvist, MD, PhD | Akershus University Hospital and University of Oslo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital | Recruiting | Lørenskog | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25112307 | Background | Kristoffersen ES, Straand J, Vetvik KG, Benth JS, Russell MB, Lundqvist C. Brief intervention for medication-overuse headache in primary care. The BIMOH study: a double-blind pragmatic cluster randomised parallel controlled trial. J Neurol Neurosurg Psychiatry. 2015 May;86(5):505-12. doi: 10.1136/jnnp-2014-308548. Epub 2014 Aug 11. | |
| 25179065 |
| Label | URL |
|---|---|
| Humeniuk et al (2010), WHO: The Alcohol, Smoking and Substance involvement Screening Test (ASSIST): manual for use in primary care | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan: Statistical analysis plan screening data | Aug 23, 2024 | Aug 23, 2024 | SAP_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Statistical analysis plan main RCT | Nov 13, 2024 | Nov 13, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003419 | Crisis Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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.
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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.
| 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 |
Euro QoL, five dimension, 5 level version (EQ-5D VAS), 0-100 with 100 representing best health
| 6 months |
| Dependence score | Severity of dependence score (SDS), 0-15, 15 highest severity | 6 weeks |
| Dependence score | Severity of dependence score (SDS), 0-15, 15 highest severity | 6 months |
| MoCa score | Telefon - Montreal Cognitive Assessment (T-MoCA) for remote assessments. (0-22 points, normal cognition ≥ 18 / 22) | 6 weeks |
| Self assessed cognitive function | Norwegian cognitive function instrument (KFI) (0-13 points yes=1 point, maybe=0,5 point, no=0 point) | 6 weeks |
| Verbal fluency | FAS score (60 seconds timecap, using a cut-off score of 14 points indicating executive function deficits) | 6 weeks |
| Multimorbidity | Cumulative Illness Rating Scale-Geriatric (CIRS-G) 0-56, 56 worst | 6 weeks |
| Multimorbidity | Cumulative Illness Rating Scale-Geriatric (CIRS-G) 0-56, 56 worst | 12 months |
| Polypharmacy | Number of regularly used medications | 6 weeks |
| Readiness to change behaviour | Readiness to change behavior visual analogue scale scale, 0-100, 100 most ready | Baseline |
| Prevalence of inappropriate medication use in screened population | Patient self report in screening questionnaire | At screening before baseline |
| Prevalence self-reported sleep difficulties | Patient self report in screening questionnaire | At screening before baseline |
| Anxiety and depression symptoms | Hospital anxiety and depression scale (HADS), 0-42, 42 worst | 6 weeks |
| Anxiety and depression symptoms | Hospital anxiety and depression scale (HADS), 0-42, 42 worst | 6 months |
| Mortality | Based on automatic registration in electronic patient journal | 12 months, 24 months |
| Cognitive function, subdimensions | Cognistat test, subdimensions score, higher score is better cognitive function | 6 weeks |
| Cognitive function, subdimensions | Cognistat test, subdimensions score, higher score is better cognitive function | 6 months |
| Inappropriate Z-hypnotics use | Proportion of patients with prolonged use of Z-hypnotics | 6 months |
| Pain visual analogue scale (VAS) | VAS assessment of experienced pain (1-100 mm, no pain (0), worst possible pain (100)) | 12 months |
| Cognitive function | Cognistat test total score (0-84, 84 best) | 12 months |
| Inappropriate Z-hypnotics use | Proportion of patients with prolonged use of Z-hypnotics | 12 months |
| Change compared to baseline of Z-hypnotics use | Proportion of patients with prolonged use of Z-hypnotics | 12 months |
| Quality of life measure, index | Euro QoL, five dimension, 5 level version (EQ-5D-5L index, Norwegian population norms valuation) | 12 months |
| Quality of life measure, VAS | Euro QoL, 0 (worse) - 100(best)score (EQ-5D VAS) | 12 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. .) | 12 months |
| Pain visual analogue scale (VAS) | VAS assessment of experienced pain (1-100 mm, no pain (0), worst possible pain (100)) | 6 months |
| Frich JC, Kristoffersen ES, Lundqvist C. GPs' experiences with brief intervention for medication-overuse headache: a qualitative study in general practice. Br J Gen Pract. 2014 Sep;64(626):e525-31. doi: 10.3399/bjgp14X681313. |
| 26645391 | Background | Kristoffersen ES, Straand J, Vetvik KG, Benth JS, Russell MB, Lundqvist C. Brief intervention by general practitioners for medication-overuse headache, follow-up after 6 months: a pragmatic cluster-randomised controlled trial. J Neurol. 2016 Feb;263(2):344-353. doi: 10.1007/s00415-015-7975-1. Epub 2015 Dec 8. |
| 28544265 | Background | Kristoffersen ES, Straand J, Russell MB, Lundqvist C. Lasting improvement of medication-overuse headache after brief intervention - a long-term follow-up in primary care. Eur J Neurol. 2017 Jul;24(7):883-891. doi: 10.1111/ene.13318. Epub 2017 May 23. |
| 31234786 | Background | Cheng S, Siddiqui TG, Gossop M, Kristoffersen ES, Lundqvist C. The Severity of Dependence Scale detects medication misuse and dependence among hospitalized older patients. BMC Geriatr. 2019 Jun 24;19(1):174. doi: 10.1186/s12877-019-1182-3. |
| 32718926 | Background | Siddiqui TG, Cheng S, Gossop M, Kristoffersen ES, Grambaite R, Lundqvist C. Association between prescribed central nervous system depressant drugs, comorbidity and cognition among hospitalised older patients: a cross-sectional study. BMJ Open. 2020 Jul 27;10(7):e038432. doi: 10.1136/bmjopen-2020-038432. |
| 33143713 | Background | Siddiqui TG, Cheng S, Mellingsaeter M, Grambaite R, Gulbrandsen P, Lundqvist C, Gerwing J. "What should I do when I get home?" treatment plan discussion at discharge between specialist physicians and older in-patients: mixed method study. BMC Health Serv Res. 2020 Nov 3;20(1):1002. doi: 10.1186/s12913-020-05860-9. |
| 34913326 | Background | Bjelkaroy MT, Cheng S, Siddiqui TG, Benth JS, Grambaite R, Kristoffersen ES, Lundqvist C. The association between pain and central nervous system depressing medication among hospitalised Norwegian older adults. Scand J Pain. 2021 Dec 16;22(3):483-493. doi: 10.1515/sjpain-2021-0120. Print 2022 Jul 26. |
| 35239678 | Background | Siddiqui TG, Bjelkaroy MT, Cheng S, Kristoffersen ES, Grambaite R, Lundqvist C. The effect of cognitive function and central nervous system depressant use on mortality-A prospective observational study of previously hospitalised older patients. PLoS One. 2022 Mar 3;17(3):e0263024. doi: 10.1371/journal.pone.0263024. eCollection 2022. |
| 42031000 | Derived | Siddiqui TG, Simonsen THB, Lie Selle M, Lundqvist C. Brief intervention for inappropriate z-hypnotics use in older adults: a before and after intervention study in primary care. Scand J Prim Health Care. 2026 Dec;44(1):2660168. doi: 10.1080/02813432.2026.2660168. Epub 2026 Apr 24. |
| 41680650 | Derived | Siddiqui TG, Simonsen TB, Bjelkaroy MT, Selle ML, Lundqvist C. A brief intervention to discontinue inappropriate z-hypnotics use by older patients in primary care: a randomised controlled trial. BMC Prim Care. 2026 Feb 13;27(1):97. doi: 10.1186/s12875-026-03212-w. |
| Babor et al (2001), WHO: Brief intervention for hazardous and harmful drinking : a manual for use in primary care | View source |
| D001523 |
| Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |