Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2015-05-31
2017-09-30
Brief Summary
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The investigators are planning an intervention with the screening tool Screening Tool of Older Person's potentially inappropriate Prescription/Screening tool to Alert to Right Treatment (STOPP/START ) criteria to evaluate medication lists of the participating patients.
Detailed Description
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The recruitment will be done as follows:
The patients will be screened according to inclusion criteria. Afterwards each patient will be invited to a first meeting that explains the aim of the study, giving the opportunity for discussion and consideration, and presenting the consent information. After giving the consent the patient will be invited to a second meeting with blood tests, data registration, medication registration, undergoing MMS and handing over the questionnaires forms.
Randomization:
After the initial assessment and compliance with the eligibility criteria, participants will be randomized into an intervention group (medication list will be evaluated by STOPP/START criteria) and a control group (medication list will not be evaluated by STOPP/START criteria). Randomization numbers will be generated by a random number generator. A series of numbered, sealed, opaque envelopes will be used to ensure confidentiality. Each envelope will contain a card with information about the group allocation. The group allocation is concealed from the researcher and patients at baseline registration.
Each patients will get questionnaires for: Quality of life using Kidney Disease Quality of Life - Short form 36 (KDQOL-Short form 36 ) and EuroQoL-3D (EQ-3D), beliefs about medicine, Hospital Anxiety and Depression Scale (HADS), Morisky medication adherence scale and visual adherence scale (VAS), sleeping related questionnaires (Epworth, Berlin, Pittsburgh). A Mini Mental Status (MMS) test will be done regarding cognitive function.
Each patients will get the opportunity to have a polysomnograph for one night.
With STOPP/START criteria the medication list will be evaluated for the patients who are randomized in the intervention group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention group
Medication lists from the patients randomized in the intervention group will be evaluated by the research physician with the help of STOPP/START criteria.
Feedback of this screening will be given to the team responsible for patient treatment.
STOPP/START criteria
Evaluation of medication lists
Control
Patients in this arm will receive standard pharmacological treatment
No interventions assigned to this group
Interventions
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STOPP/START criteria
Evaluation of medication lists
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients diagnosed with dementia or severe cognitive disorder (MMS \< 25),
* Patients with hearing impairment
* Patients with language difficulties
65 Years
ALL
No
Sponsors
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University Hospital, Akershus
OTHER
Responsible Party
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Krystina Parker
MD, pHD-student
Principal Investigators
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Knut Stavem, Professor
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Akershus
Ingrid Os
Role: PRINCIPAL_INVESTIGATOR
Univeristy Hospital, Ullevål
Locations
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Vestre Viken Sykehus
Drammen, , Norway
University Hospital, Ullevål
Oslo, , Norway
University Hospital, Akershus
Oslo, , Norway
Countries
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References
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Parker K, Bull-Engelstad I, Benth JS, Aasebo W, von der Lippe N, Reier-Nilsen M, Os I, Stavem K. Effectiveness of using STOPP/START criteria to identify potentially inappropriate medication in people aged >/= 65 years with chronic kidney disease: a randomized clinical trial. Eur J Clin Pharmacol. 2019 Nov;75(11):1503-1511. doi: 10.1007/s00228-019-02727-9. Epub 2019 Jul 29.
Other Identifiers
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15-068
Identifier Type: -
Identifier Source: org_study_id