Health TrialsbyHealthPanel

Brief Intervention for Sleep Medication Misuse Among Elderly

ConditionHarmful Use of Hypnotic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity Hospital, Akershus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Self-reported use of Z-hypnotics > 4 days per week and > 4 weeks

Disqualifiers

diagnosis of dementia,

diagnosis of psychosis,

diagnosis of major depression,

diagnosis of delirium,

Trial design

Design model

Parallel

Treatments tested in this trial

  • BI (Brief Intervention)

    Behavioral

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: BI (Brief Intervention)Active comparator 1 intervention
Group B: BAU (Business as usual)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Inappropriate Z-hypnotics use

Proportion of patients with prolonged use of Z-hypnotics

Time frame
6 weeks

Secondary outcomes

1

Pain visual analogue scale (VAS)

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

Time frame
6 weeks
2

Cognitive function

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

Time frame
6 weeks
3

Cognitive function

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

Time frame
6 months
4

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. .)

Time frame
6 weeks

Other outcomes

1

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

Time frame
6 months
2

Quality of life measure, VAS

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

Time frame
6 months
3

Dependence score

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

Time frame
6 weeks
4

Dependence score

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

Time frame
6 months

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Akershus University HospitalRecruiting LørenskogNorwayNorway

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Akershus

Lead sponsor

University of Oslo

Collaborator

Source ClinicalTrials.gov
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