STOPP/START criteria
OtherEvaluation of medication lists
NCT Number: NCT02424786
The study aims to investigate adherence and polypharmacy in elderly patients with chronic kidney disease (CKD) and End Stage Renal Disease (ESRD). The investigators look into possible factors or predictors that may affect adherence and reduce polypharmacy. Factors could be: quality of life, anxiety and depression, beliefs about medicine and cognitive impairment.
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.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
Vestre Viken Sykehus, Drammen, Norway
The investigators intend to include all patients > 65 years old, in dialysis treatment (hemodialysis and peritoneal dialysis), as well as patients with CKD stage 5.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Evaluation of medication lists
Time frame: 6 months - 1 year
Adherence measured by Morisky medication adherence scale and visual adherence scale
Time frame: 1-2 year
Randomization of all patients into intervention group and control group. Comparing both groups by using STOPP/START criteria with the aim to assess numbers of patients with inappropriate medications
Time frame: 1-2 year
Randomization of all patients into intervention group and control group with the aim to improve adherence by using Morisky medication adherence scale and visual adherence scale
Time frame: 1-2 years
Questionnaires about: Beliefs about medicine, depression and anxiety (measured by HADS), quality of life (measured by KDQOL-Short form 36, EQ-5D), and adherence (measured by Morisky medication adherence scale and visual adherence scale)
Time frame: 6 months - 1 year
Questionnaires about depression and anxiety (HADS)
Time frame: 6 months - 1 year
Questionnaires about beliefs about medicine
Time frame: 6 months - 1 year
Questionnaires about sleep quality (Epworth, Berlin, Pittsburgh questionnaires)
Time frame: 6 months - 1 year
Questionnaires about quality of life measured by KDQOL-Short form 36 and EQ-5D
Time frame: baseline and 6 months
Improvement of polypharmacy
Time frame: baseline
Difference between Morisky medication scale score and score from the Visual adherence score
University Hospital, Akershus
Other
Non-adherence and Polypharmacy in Elderly Patients With Chronic Renal Failure: Predictors and an Intervention
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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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