Adherence
Conditions
Keywords
Adherence, Polypharmacy, Elderly, Chronic kidney disease
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.
Interventions
OTHERSTOPP/START criteria
Evaluation of medication lists
Sponsors
University Hospital, Akershus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence for medication non-adherence | 6 months - 1 year | Adherence measured by Morisky medication adherence scale and visual adherence scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of polypharmacy | 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 |
| Improvement of adherence | 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 |
| Association between beliefs about medication and anxiety and depression with medication non-adherence and quality of life | 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) |
| Predictors for medication non-adherence | 6 months - 1 year | Questionnaires about depression and anxiety (HADS) |
| Medication non-adherence risk factors | 6 months - 1 year | Questionnaires about sleep quality (Epworth, Berlin, Pittsburgh questionnaires) |
| Non-adherence and medication - predictors | 6 months - 1 year | Questionnaires about quality of life measured by KDQOL-Short form 36 and EQ-5D |
| Risk factors for medication non-adherence | 6 months - 1 year | Questionnaires about beliefs about medicine |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline regarding prescription of inappropriate medications in the intervention group | baseline and 6 months | Improvement of polypharmacy |
| Change from baseline in Morisky medication adherence scale and visual adherence scale | baseline | Difference between Morisky medication scale score and score from the Visual adherence score |
Countries
Norway
Outcome results
None listed