xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06032715</url>
    </required_header>
    <id_info>
      <org_study_id>BI-sleep</org_study_id>
      <nct_id>NCT06032715</nct_id>
    </id_info>
    <brief_title>Brief Intervention for Sleep Medication Misuse Among Elderly</brief_title>
    <acronym>BI-sleep</acronym>
    <official_title>Brief Intervention for Reducing Prolonged Use of Sleep Medication Among Elderly</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Akershus</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Oslo</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospital, Akershus</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Randomized controlled trial to evaluate effectiveness of behavioral Brief Intervention&#xD;
        administered by General practitioners (GPs) versus business as usual on use of Z-hypnotics by&#xD;
        elderly patients in primary care.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Two armed study with controlled masked first part over 6 months. Active arm is with Brief&#xD;
        Intervention for inappropriate use of Z-hypnotics among elderly with intervention delivered&#xD;
        by trained GPs. Control arm is for patients handled by their (non-trained) GPs with business&#xD;
        as usual (BAU). Main outcome is 6 weeks after intervention with additional data collection&#xD;
        points after 6 months (blinded) and long-term follow-up to 12 months (open). After 6 months&#xD;
        there will be an open single crossover as BAU GPs will then also receive training in the&#xD;
        Brief Intervention method.&#xD;
  &#xD;
        Baseline assessments are limited to self reports and automatic sleep assessment with&#xD;
        actigraphy to avoid assessment effects. Follow-up at main outcome time point is in person,&#xD;
        some outcomes are also by telephone assessment and compared to baseline prior to intervention&#xD;
        (e g Actigraphy assessment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 11, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <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.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <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.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Inappropriate Z-hypnotics use</measure>
      <time_frame>6 weeks</time_frame>
      <description>Proportion of patients with prolonged use of Z-hypnotics</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain visual analogue scale (VAS)</measure>
      <time_frame>6 months</time_frame>
      <description>VAS assessment of experienced pain (1-100 mm, no pain (0), worst possible pain (100))</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive function</measure>
      <time_frame>6 weeks</time_frame>
      <description>Cognistat test total score (0-84, 84 best)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive function</measure>
      <time_frame>6 months</time_frame>
      <description>Cognistat test total score (0-84, 84 best)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Experience of sleep</measure>
      <time_frame>6 weeks</time_frame>
      <description>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. .)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Experience of sleep</measure>
      <time_frame>6 months</time_frame>
      <description>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. .)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep efficiency (random subpopulation)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Actigraphy assessed before and after intervention</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change compared to baseline of Z-hypnotics use</measure>
      <time_frame>6 weeks</time_frame>
      <description>Proportion of patients with prolonged use of Z-hypnotics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change compared to baseline of Z-hypnotics use</measure>
      <time_frame>6 months</time_frame>
      <description>Proportion of patients with prolonged use of Z-hypnotics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Inappropriate Z-hypnotics use</measure>
      <time_frame>baseline</time_frame>
      <description>Proportion of patients with prolonged use of Z-hypnotics</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Quality of life measure, index</measure>
      <time_frame>6 months</time_frame>
      <description>Euro QoL, five dimension, 5 level version (EQ-5D-5L index, Norwegian population norms valuation), 0-1 with 1 representing perfect health</description>
    </other_outcome>
    <other_outcome>
      <measure>Quality of life measure, VAS</measure>
      <time_frame>6 months</time_frame>
      <description>Euro QoL, five dimension, 5 level version (EQ-5D VAS), 0-100 with 100 representing best health</description>
    </other_outcome>
    <other_outcome>
      <measure>Dependence score</measure>
      <time_frame>6 weeks</time_frame>
      <description>Severity of dependence score (SDS), 0-15, 15 highest severity</description>
    </other_outcome>
    <other_outcome>
      <measure>Dependence score</measure>
      <time_frame>6 months</time_frame>
      <description>Severity of dependence score (SDS), 0-15, 15 highest severity</description>
    </other_outcome>
    <other_outcome>
      <measure>MoCa score</measure>
      <time_frame>6 weeks</time_frame>
      <description>Telefon - Montreal Cognitive Assessment (T-MoCA) for remote assessments. (0-22 points, normal cognition ≥ 18 / 22)</description>
    </other_outcome>
    <other_outcome>
      <measure>Self assessed cognitive function</measure>
      <time_frame>6 weeks</time_frame>
      <description>Norwegian cognitive function instrument (KFI) (0-13 points yes=1 point, maybe=0,5 point, no=0 point)</description>
    </other_outcome>
    <other_outcome>
      <measure>Verbal fluency</measure>
      <time_frame>6 weeks</time_frame>
      <description>FAS score (60 seconds timecap, using a cut-off score of 14 points indicating executive function deficits)</description>
    </other_outcome>
    <other_outcome>
      <measure>Multimorbidity</measure>
      <time_frame>6 weeks</time_frame>
      <description>Cumulative Illness Rating Scale-Geriatric (CIRS-G) 0-56, 56 worst</description>
    </other_outcome>
    <other_outcome>
      <measure>Multimorbidity</measure>
      <time_frame>12 months</time_frame>
      <description>Cumulative Illness Rating Scale-Geriatric (CIRS-G) 0-56, 56 worst</description>
    </other_outcome>
    <other_outcome>
      <measure>Polypharmacy</measure>
      <time_frame>6 weeks</time_frame>
      <description>Number of regularly used medications</description>
    </other_outcome>
    <other_outcome>
      <measure>Readiness to change behaviour</measure>
      <time_frame>Baseline</time_frame>
      <description>Readiness to change behavior visual analogue scale scale, 0-100, 100 most ready</description>
    </other_outcome>
    <other_outcome>
      <measure>Prevalence of inappropriate medication use in screened population</measure>
      <time_frame>At screening before baseline</time_frame>
      <description>Patient self report in screening questionnaire</description>
    </other_outcome>
    <other_outcome>
      <measure>Prevalence self-reported sleep difficulties</measure>
      <time_frame>At screening before baseline</time_frame>
      <description>Patient self report in screening questionnaire</description>
    </other_outcome>
    <other_outcome>
      <measure>Anxiety and depression symptoms</measure>
      <time_frame>6 weeks</time_frame>
      <description>Hospital anxiety and depression scale (HADS), 0-42, 42 worst</description>
    </other_outcome>
    <other_outcome>
      <measure>Anxiety and depression symptoms</measure>
      <time_frame>6 months</time_frame>
      <description>Hospital anxiety and depression scale (HADS), 0-42, 42 worst</description>
    </other_outcome>
    <other_outcome>
      <measure>Mortality</measure>
      <time_frame>12 months, 24 months</time_frame>
      <description>Based on automatic registration in electronic patient journal</description>
    </other_outcome>
    <other_outcome>
      <measure>Cognitive function, subdimensions</measure>
      <time_frame>6 weeks</time_frame>
      <description>Cognistat test, subdimensions score, higher score is better cognitive function</description>
    </other_outcome>
    <other_outcome>
      <measure>Cognitive function, subdimensions</measure>
      <time_frame>6 months</time_frame>
      <description>Cognistat test, subdimensions score, higher score is better cognitive function</description>
    </other_outcome>
    <other_outcome>
      <measure>Inappropriate Z-hypnotics use</measure>
      <time_frame>6 months</time_frame>
      <description>Proportion of patients with prolonged use of Z-hypnotics</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain visual analogue scale (VAS)</measure>
      <time_frame>12 months</time_frame>
      <description>VAS assessment of experienced pain (1-100 mm, no pain (0), worst possible pain (100))</description>
    </other_outcome>
    <other_outcome>
      <measure>Cognitive function</measure>
      <time_frame>12 months</time_frame>
      <description>Cognistat test total score (0-84, 84 best)</description>
    </other_outcome>
    <other_outcome>
      <measure>Inappropriate Z-hypnotics use</measure>
      <time_frame>12 months</time_frame>
      <description>Proportion of patients with prolonged use of Z-hypnotics</description>
    </other_outcome>
    <other_outcome>
      <measure>Change compared to baseline of Z-hypnotics use</measure>
      <time_frame>12 months</time_frame>
      <description>Proportion of patients with prolonged use of Z-hypnotics</description>
    </other_outcome>
    <other_outcome>
      <measure>Quality of life measure, index</measure>
      <time_frame>12 months</time_frame>
      <description>Euro QoL, five dimension, 5 level version (EQ-5D-5L index, Norwegian population norms valuation)</description>
    </other_outcome>
    <other_outcome>
      <measure>Quality of life measure, VAS</measure>
      <time_frame>12 months</time_frame>
      <description>Euro QoL, 0 (worse) - 100(best)score (EQ-5D VAS)</description>
    </other_outcome>
    <other_outcome>
      <measure>Experience of sleep</measure>
      <time_frame>12 months</time_frame>
      <description>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. .)</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Harmful Use of Hypnotic</condition>
    <arm_group>
      <arm_group_label>BI (Brief Intervention)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients whose GPs have been taught the behavioral BI intervention aiming to reduce prolonged use of Z-hypnotics.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>BAU (Business as usual)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <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.&#xD;
  This group also constitutes an open cross-over group to active intervention once the masked 6 months phase is completed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>BI (Brief Intervention)</intervention_name>
      <description>Short structured individual behavioral intervention to reduce inappropriate usage of Z-hypnotics</description>
      <arm_group_label>BI (Brief Intervention)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Self-reported use of Z-hypnotics &gt; 4 days per week and &gt; 4 weeks&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  diagnosis of dementia,&#xD;
  &#xD;
            -  diagnosis of psychosis,&#xD;
  &#xD;
            -  diagnosis of major depression,&#xD;
  &#xD;
            -  diagnosis of delirium,&#xD;
  &#xD;
            -  unable to give informed consent,&#xD;
  &#xD;
            -  insufficient Norwegian language capacity to complete tests&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Christofer Lundqvist, MD, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Akershus University Hospital and University of Oslo</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tahreem G Siddiqui, PhD</last_name>
      <phone>90600984</phone>
      <phone_ext>+47</phone_ext>
      <email>tahs@ahus.no</email>
    </overall_contact>
    <link>
      <url>https://apps.who.int/iris/handle/10665/44320</url>
      <description>Humeniuk et al (2010), WHO: The Alcohol, Smoking and Substance involvement Screening Test (ASSIST): manual for use in primary care</description>
    </link>
    <link>
      <url>https://apps.who.int/iris/handle/10665/67210</url>
      <description>Babor et al (2001), WHO: Brief intervention for hazardous and harmful drinking : a manual for use in primary care</description>
    </link>
    <reference>
      <citation>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.</citation>
      <PMID>25112307</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>25179065</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>26645391</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>28544265</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>31234786</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>32718926</PMID>
    </reference>
    <reference>
      <citation>Siddiqui TG, Cheng S, Mellingsaeter M, Grambaite R, Gulbrandsen P, Lundqvist C, Gerwing J. &quot;What should I do when I get home?&quot; 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.</citation>
      <PMID>33143713</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>34913326</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>35239678</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Hospital, Akershus</investigator_affiliation>
      <investigator_full_name>Christofer Lundqvist</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Z-hypnotics</keyword>
    <keyword>insomnia</keyword>
    <keyword>sleep</keyword>
    <keyword>side effects</keyword>
    <keyword>cognitive function</keyword>
    <keyword>pain</keyword>
    <keyword>behavioral intervention</keyword>
    <keyword>dependence</keyword>
    <keyword>quality of life</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06032715
  org study id: BI-sleep
  nct id: NCT06032715
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  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.
  primary purpose: Health Services Research
  masking: Quadruple (Participant, Care Provider, 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.
  measure: Inappropriate Z-hypnotics use
  time frame: 6 weeks
  description: Proportion of patients with prolonged use of Z-hypnotics
  measure: Pain visual analogue scale (VAS)
  time frame: 6 months
  description: VAS assessment of experienced pain (1-100 mm, no pain (0), worst possible pain (100))
  measure: Cognitive function
  time frame: 6 weeks
  description: Cognistat test total score (0-84, 84 best)
  measure: Cognitive function
  time frame: 6 months
  description: Cognistat test total score (0-84, 84 best)
  measure: Experience of sleep
  time frame: 6 weeks
  description: 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. .)
  measure: Experience of sleep
  time frame: 6 months
  description: 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. .)
  measure: Sleep efficiency (random subpopulation)
  time frame: 6 weeks
  description: Actigraphy assessed before and after intervention
  measure: Change compared to baseline of Z-hypnotics use
  time frame: 6 weeks
  description: Proportion of patients with prolonged use of Z-hypnotics
  measure: Change compared to baseline of Z-hypnotics use
  time frame: 6 months
  description: Proportion of patients with prolonged use of Z-hypnotics
  measure: Inappropriate Z-hypnotics use
  time frame: baseline
  description: Proportion of patients with prolonged use of Z-hypnotics
  measure: Quality of life measure, index
  time frame: 6 months
  description: Euro QoL, five dimension, 5 level version (EQ-5D-5L index, Norwegian population norms valuation), 0-1 with 1 representing perfect health
  measure: Quality of life measure, VAS
  time frame: 6 months
  description: Euro QoL, five dimension, 5 level version (EQ-5D VAS), 0-100 with 100 representing best health
  measure: Dependence score
  time frame: 6 weeks
  description: Severity of dependence score (SDS), 0-15, 15 highest severity
  measure: Dependence score
  time frame: 6 months
  description: Severity of dependence score (SDS), 0-15, 15 highest severity
  measure: MoCa score
  time frame: 6 weeks
  description: Telefon - Montreal Cognitive Assessment (T-MoCA) for remote assessments. (0-22 points, normal cognition ≥ 18 / 22)
  measure: Self assessed cognitive function
  time frame: 6 weeks
  description: Norwegian cognitive function instrument (KFI) (0-13 points yes=1 point, maybe=0,5 point, no=0 point)
  measure: Verbal fluency
  time frame: 6 weeks
  description: FAS score (60 seconds timecap, using a cut-off score of 14 points indicating executive function deficits)
  measure: Multimorbidity
  time frame: 6 weeks
  description: Cumulative Illness Rating Scale-Geriatric (CIRS-G) 0-56, 56 worst
  measure: Multimorbidity
  time frame: 12 months
  description: Cumulative Illness Rating Scale-Geriatric (CIRS-G) 0-56, 56 worst
  measure: Polypharmacy
  time frame: 6 weeks
  description: Number of regularly used medications
  measure: Readiness to change behaviour
  time frame: Baseline
  description: Readiness to change behavior visual analogue scale scale, 0-100, 100 most ready
  measure: Prevalence of inappropriate medication use in screened population
  time frame: At screening before baseline
  description: Patient self report in screening questionnaire
  measure: Prevalence self-reported sleep difficulties
  time frame: At screening before baseline
  description: Patient self report in screening questionnaire
  measure: Anxiety and depression symptoms
  time frame: 6 weeks
  description: Hospital anxiety and depression scale (HADS), 0-42, 42 worst
  measure: Anxiety and depression symptoms
  time frame: 6 months
  description: Hospital anxiety and depression scale (HADS), 0-42, 42 worst
  measure: Mortality
  time frame: 12 months, 24 months
  description: Based on automatic registration in electronic patient journal
  measure: Cognitive function, subdimensions
  time frame: 6 weeks
  description: Cognistat test, subdimensions score, higher score is better cognitive function
  measure: Cognitive function, subdimensions
  time frame: 6 months
  description: Cognistat test, subdimensions score, higher score is better cognitive function
  measure: Inappropriate Z-hypnotics use
  time frame: 6 months
  description: Proportion of patients with prolonged use of Z-hypnotics
  measure: Pain visual analogue scale (VAS)
  time frame: 12 months
  description: VAS assessment of experienced pain (1-100 mm, no pain (0), worst possible pain (100))
  measure: Cognitive function
  time frame: 12 months
  description: Cognistat test total score (0-84, 84 best)
  measure: Inappropriate Z-hypnotics use
  time frame: 12 months
  description: Proportion of patients with prolonged use of Z-hypnotics
  measure: Change compared to baseline of Z-hypnotics use
  time frame: 12 months
  description: Proportion of patients with prolonged use of Z-hypnotics
  measure: Quality of life measure, index
  time frame: 12 months
  description: Euro QoL, five dimension, 5 level version (EQ-5D-5L index, Norwegian population norms valuation)
  measure: Quality of life measure, VAS
  time frame: 12 months
  description: Euro QoL, 0 (worse) - 100(best)score (EQ-5D VAS)
  measure: Experience of sleep
  time frame: 12 months
  description: 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. .)
  arm group label: BI (Brief Intervention)
  arm group type: Active Comparator
  description: Patients whose GPs have been taught the behavioral BI intervention aiming to reduce prolonged use of Z-hypnotics.
  arm group label: BAU (Business as usual)
  arm group type: No Intervention
  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.
  intervention type: Behavioral
  intervention name: BI (Brief Intervention)
  description: Short structured individual behavioral intervention to reduce inappropriate usage of Z-hypnotics
  arm group label: BI (Brief Intervention)
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Christofer Lundqvist, MD, PhD
  role: Study Chair
  affiliation: Akershus University Hospital and University of Oslo
  last name: Tahreem G Siddiqui, PhD
  phone: 90600984
  phone ext: +47
  email: tahs@ahus.no
  url: https://apps.who.int/iris/handle/10665/44320
  description: Humeniuk et al (2010), WHO: The Alcohol, Smoking and Substance involvement Screening Test (ASSIST): manual for use in primary care
  url: https://apps.who.int/iris/handle/10665/67210
  description: Babor et al (2001), WHO: Brief intervention for hazardous and harmful drinking : a manual for use in primary care
  citation: 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.
  PMID: 25112307
  citation: 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.
  PMID: 25179065
  citation: 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.
  PMID: 26645391
  citation: 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.
  PMID: 28544265
  citation: 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.
  PMID: 31234786
  citation: 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.
  PMID: 32718926
  citation: 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.
  PMID: 33143713
  citation: 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.
  PMID: 34913326
  citation: 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.
  PMID: 35239678
  responsible party type: Principal Investigator
  investigator affiliation: University Hospital, Akershus
  investigator full name: Christofer Lundqvist
  investigator title: Professor