Non-adherence and Polypharmacy in Elderly Patients

Adherence Clinical Trial

Official title:

Non-adherence and Polypharmacy in Elderly Patients With Chronic Renal Failure: Predictors and an Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424786
• Other study ID #: 15-068
• Status: Completed
• Phase: N/A
• First received: March 31, 2015
• Last updated: September 19, 2017
• Start date: May 2015
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence

Intervention

Other:
• STOPP/START criteria
Evaluation of medication lists

Locations

Country	Name	City	State
Norway	Vestre Viken Sykehus	Drammen
Norway	University Hospital, Akershus	Oslo
Norway	University Hospital, Ullevål	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline regarding prescription of inappropriate medications in the intervention group	Improvement of polypharmacy	baseline and 6 months
Other	Change from baseline in Morisky medication adherence scale and visual adherence scale	Difference between Morisky medication scale score and score from the Visual adherence score	baseline
Primary	Prevalence for medication non-adherence	Adherence measured by Morisky medication adherence scale and visual adherence scale	6 months - 1 year
Secondary	Improvement of polypharmacy	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	1-2 year
Secondary	Improvement of adherence	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	1-2 year
Secondary	Association between beliefs about medication and anxiety and depression with medication non-adherence and quality of life	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)	1-2 years
Secondary	Predictors for medication non-adherence	Questionnaires about depression and anxiety (HADS)	6 months - 1 year
Secondary	Risk factors for medication non-adherence	Questionnaires about beliefs about medicine	6 months - 1 year
Secondary	Medication non-adherence risk factors	Questionnaires about sleep quality (Epworth, Berlin, Pittsburgh questionnaires)	6 months - 1 year
Secondary	Non-adherence and medication - predictors	Questionnaires about quality of life measured by KDQOL-Short form 36 and EQ-5D	6 months - 1 year