Non-adherence and Polypharmacy in Elderly Patients

Not Applicable

Completed

• Conditions: Adherence
• Interventions: Other: STOPP/START criteria

• Registration Number: NCT02424786
• Lead Sponsor: University Hospital, Akershus

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.

Study Timeline

• Study First Submitted: 2015-03-31
• Study First Submitted QC: 2015-04-22
• Study First Posted: 2015-04-23
• Study Start: 2015-05
• Status Verified: 2017-09
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Last Update Submitted: 2017-09-19
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	STOPP/START criteria	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.

Primary Outcome Measures

Name	Time	Method
Prevalence for medication non-adherence	6 months - 1 year	Adherence measured by Morisky medication adherence scale and visual adherence scale

Secondary Outcome Measures

Name	Time	Method
Risk factors for medication non-adherence	6 months - 1 year	Questionnaires about beliefs about medicine
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)
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
Predictors for medication non-adherence	6 months - 1 year	Questionnaires about depression and anxiety (HADS)
Non-adherence and medication - predictors	6 months - 1 year	Questionnaires about quality of life measured by KDQOL-Short form 36 and EQ-5D
Medication non-adherence risk factors	6 months - 1 year	Questionnaires about sleep quality (Epworth, Berlin, Pittsburgh questionnaires)

Trial Locations

Locations (3)

Vestre Viken Sykehus; 🇳🇴 Drammen, Norway

University Hospital, Akershus; 🇳🇴 Oslo, Norway

University Hospital, Ullevål; 🇳🇴 Oslo, Norway