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NCT Number: NCT06032715

Brief Intervention for Sleep Medication Misuse Among Elderly

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.

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Key information

Conditions

Harmful Use of Hypnotic Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akershus University Hospital

Lørenskog, Norway

Location status: Recruiting

Location contact

C Lundqvist, MD, PhD

CONTACT

Christofer Lundqvist, MD, PhD

PRINCIPAL_INVESTIGATOR

Tahreem G Siddiqui, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BI (Brief Intervention)

Behavioral

Short structured individual behavioral intervention to reduce inappropriate usage of Z-hypnotics

Primary outcomes

  1. Inappropriate Z-hypnotics use

    Time frame: 6 weeks

    Proportion of patients with prolonged use of Z-hypnotics

Secondary outcomes

  1. Pain visual analogue scale (VAS)

    Time frame: 6 weeks

    VAS assessment of experienced pain (1-100 mm, no pain (0), worst possible pain (100))

  2. Cognitive function

    Time frame: 6 weeks

    Cognistat test total score (0-84, 84 best)

  3. Cognitive function

    Time frame: 6 months

    Cognistat test total score (0-84, 84 best)

  4. Experience of sleep

    Time frame: 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. .)

  5. Experience of sleep

    Time frame: 6 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. .)

  6. Sleep efficiency (random subpopulation)

    Time frame: 6 weeks

    Actigraphy assessed before and after intervention

  7. Change compared to baseline of Z-hypnotics use

    Time frame: 6 weeks

    Proportion of patients with prolonged use of Z-hypnotics

  8. Change compared to baseline of Z-hypnotics use

    Time frame: 6 months

    Proportion of patients with prolonged use of Z-hypnotics

  9. Inappropriate Z-hypnotics use

    Time frame: baseline

    Proportion of patients with prolonged use of Z-hypnotics

Other outcomes

  1. Quality of life measure, index

    Time frame: 6 months

    Euro QoL, five dimension, 5 level version (EQ-5D-5L index, Norwegian population norms valuation), 0-1 with 1 representing perfect health

  2. Quality of life measure, VAS

    Time frame: 6 months

    Euro QoL, five dimension, 5 level version (EQ-5D VAS), 0-100 with 100 representing best health

  3. Dependence score

    Time frame: 6 weeks

    Severity of dependence score (SDS), 0-15, 15 highest severity

  4. Dependence score

    Time frame: 6 months

    Severity of dependence score (SDS), 0-15, 15 highest severity

  5. MoCa score

    Time frame: 6 weeks

    Telefon - Montreal Cognitive Assessment (T-MoCA) for remote assessments. (0-22 points, normal cognition ≥ 18 / 22)

  6. Self assessed cognitive function

    Time frame: 6 weeks

    Norwegian cognitive function instrument (KFI) (0-13 points yes=1 point, maybe=0,5 point, no=0 point)

  7. Verbal fluency

    Time frame: 6 weeks

    FAS score (60 seconds timecap, using a cut-off score of 14 points indicating executive function deficits)

  8. Multimorbidity

    Time frame: 6 weeks

    Cumulative Illness Rating Scale-Geriatric (CIRS-G) 0-56, 56 worst

  9. Multimorbidity

    Time frame: 12 months

    Cumulative Illness Rating Scale-Geriatric (CIRS-G) 0-56, 56 worst

  10. Polypharmacy

    Time frame: 6 weeks

    Number of regularly used medications

  11. Readiness to change behaviour

    Time frame: Baseline

    Readiness to change behavior visual analogue scale scale, 0-100, 100 most ready

  12. Prevalence of inappropriate medication use in screened population

    Time frame: At screening before baseline

    Patient self report in screening questionnaire

  13. Prevalence self-reported sleep difficulties

    Time frame: At screening before baseline

    Patient self report in screening questionnaire

  14. Anxiety and depression symptoms

    Time frame: 6 weeks

    Hospital anxiety and depression scale (HADS), 0-42, 42 worst

  15. Anxiety and depression symptoms

    Time frame: 6 months

    Hospital anxiety and depression scale (HADS), 0-42, 42 worst

  16. Mortality

    Time frame: 12 months, 24 months

    Based on automatic registration in electronic patient journal

  17. Cognitive function, subdimensions

    Time frame: 6 weeks

    Cognistat test, subdimensions score, higher score is better cognitive function

  18. Cognitive function, subdimensions

    Time frame: 6 months

    Cognistat test, subdimensions score, higher score is better cognitive function

  19. Inappropriate Z-hypnotics use

    Time frame: 6 months

    Proportion of patients with prolonged use of Z-hypnotics

  20. Pain visual analogue scale (VAS)

    Time frame: 12 months

    VAS assessment of experienced pain (1-100 mm, no pain (0), worst possible pain (100))

  21. Cognitive function

    Time frame: 12 months

    Cognistat test total score (0-84, 84 best)

  22. Inappropriate Z-hypnotics use

    Time frame: 12 months

    Proportion of patients with prolonged use of Z-hypnotics

  23. Change compared to baseline of Z-hypnotics use

    Time frame: 12 months

    Proportion of patients with prolonged use of Z-hypnotics

  24. Quality of life measure, index

    Time frame: 12 months

    Euro QoL, five dimension, 5 level version (EQ-5D-5L index, Norwegian population norms valuation)

  25. Quality of life measure, VAS

    Time frame: 12 months

    Euro QoL, 0 (worse) - 100(best)score (EQ-5D VAS)

  26. Experience of sleep

    Time frame: 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. .)

  27. Pain visual analogue scale (VAS)

    Time frame: 6 months

    VAS assessment of experienced pain (1-100 mm, no pain (0), worst possible pain (100))

Study contacts

Contact information is provided by the study sponsor or research team.

Tahreem G Siddiqui, PhD

CONTACT

[email protected]

90600984 ext. +47

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • University of Oslo

Registry information

Official study title

Brief Intervention for Reducing Prolonged Use of Sleep Medication Among Elderly

Acronym: BI-sleep

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 13, 2023
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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