Clinical trial NCT02424786: Non-adherence and Polypharmacy in Elderly Patients
Official title: Non-adherence and Polypharmacy in Elderly Patients With Chronic Renal Failure: Predictors and an Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence
Keywords: Adherence
Polypharmacy
Elderly
Chronic kidney disease
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2015-04-23
Enrollment: 180
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All patients \> 65 years with CKD, stage 5 (eGFR ≤ 12 ml/min), or undergoing treatment with hemodialysis and peritoneal dialysis

Exclusion Criteria:

* Patients not willing to participate
* Patients diagnosed with dementia or severe cognitive disorder (MMS \< 25),
* Patients with hearing impairment
* Patients with language difficulties

Primary outcomes:
measure: Prevalence for medication non-adherence
timeFrame: 6 months - 1 year
Secondary outcomes:
measure: Improvement of polypharmacy
timeFrame: 1-2 year
measure: Improvement of adherence
timeFrame: 1-2 year
measure: Association between beliefs about medication and anxiety and depression with medication non-adherence and quality of life
timeFrame: 1-2 years
measure: Predictors for medication non-adherence
timeFrame: 6 months - 1 year
measure: Risk factors for medication non-adherence
timeFrame: 6 months - 1 year
measure: Medication non-adherence risk factors
timeFrame: 6 months - 1 year
measure: Non-adherence and medication - predictors
timeFrame: 6 months - 1 year
Other outcomes:
measure: Change from baseline regarding prescription of inappropriate medications in the intervention group
timeFrame: baseline and 6 months
measure: Change from baseline in Morisky medication adherence scale and visual adherence scale
timeFrame: baseline
Locations:
city: Drammen
country: Norway
facility: Vestre Viken Sykehus
city: Oslo
country: Norway
facility: University Hospital, Ullevål
city: Oslo
country: Norway
facility: University Hospital, Akershus
Study officials:
affiliation: University Hospital, Akershus
name: Knut Stavem, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Univeristy Hospital, Ullevål
name: Ingrid Os
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.