BI-sleep: Brief Intervention for Sleep Medication Misuse Among Elderly

Sponsor

University Hospital, Akershus (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06032715

Collaborator

University of Oslo (Other)

120

Enrollment

Arms

21.6

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Harmful Use of Hypnotic	Behavioral: BI (Brief Intervention)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

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.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.

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.

Primary Purpose:

Health Services Research

Official Title:

Brief Intervention for Reducing Prolonged Use of Sleep Medication Among Elderly

Anticipated Study Start Date :

Sep 11, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: BI (Brief Intervention) Patients whose GPs have been taught the behavioral BI intervention aiming to reduce prolonged use of Z-hypnotics.	Behavioral: BI (Brief Intervention) Short structured individual behavioral intervention to reduce inappropriate usage of Z-hypnotics
No Intervention: BAU (Business as usual) 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.

Arm

Intervention/Treatment

Active Comparator: BI (Brief Intervention)

Patients whose GPs have been taught the behavioral BI intervention aiming to reduce prolonged use of Z-hypnotics.

Behavioral: BI (Brief Intervention)

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

No Intervention: BAU (Business as usual)

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.

Outcome Measures

Primary Outcome Measures

Inappropriate Z-hypnotics use [6 weeks]
Proportion of patients with prolonged use of Z-hypnotics

Secondary Outcome Measures

Pain visual analogue scale (VAS) [6 months]
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)
Cognitive function [6 months]
Cognistat test total score (0-84, 84 best)
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. .)
Experience of sleep [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. .)
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
Change compared to baseline of Z-hypnotics use [6 months]
Proportion of patients with prolonged use of Z-hypnotics
Inappropriate Z-hypnotics use [baseline]
Proportion of patients with prolonged use of Z-hypnotics

Other Outcome Measures

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
Dependence score [6 months]
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)
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
Multimorbidity [12 months]
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
Anxiety and depression symptoms [6 weeks]
Hospital anxiety and depression scale (HADS), 0-42, 42 worst
Anxiety and depression symptoms [6 months]
Hospital anxiety and depression scale (HADS), 0-42, 42 worst
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
Cognitive function, subdimensions [6 months]
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)
Inappropriate Z-hypnotics use [12 months]
Proportion of patients with prolonged use of Z-hypnotics
Change compared to baseline of Z-hypnotics use [12 months]
Proportion of patients with prolonged use of Z-hypnotics
Quality of life measure, index [12 months]
Euro QoL, five dimension, 5 level version (EQ-5D-5L index, Norwegian population norms valuation)
Quality of life measure, VAS [12 months]
Euro QoL, 0 (worse) - 100(best)score (EQ-5D VAS)
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. .)