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NCT Number: NCT02424786

Non-adherence and Polypharmacy in Elderly Patients

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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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vestre Viken Sykehus, Drammen, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STOPP/START criteria

Other

Evaluation of medication lists

Primary outcomes

  1. Prevalence for medication non-adherence

    Time frame: 6 months - 1 year

    Adherence measured by Morisky medication adherence scale and visual adherence scale

Secondary outcomes

  1. Improvement of polypharmacy

    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

  2. Improvement of adherence

    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

  3. Association between beliefs about medication and anxiety and depression with medication non-adherence and quality of life

    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)

  4. Predictors for medication non-adherence

    Time frame: 6 months - 1 year

    Questionnaires about depression and anxiety (HADS)

  5. Risk factors for medication non-adherence

    Time frame: 6 months - 1 year

    Questionnaires about beliefs about medicine

  6. Medication non-adherence risk factors

    Time frame: 6 months - 1 year

    Questionnaires about sleep quality (Epworth, Berlin, Pittsburgh questionnaires)

  7. Non-adherence and medication - predictors

    Time frame: 6 months - 1 year

    Questionnaires about quality of life measured by KDQOL-Short form 36 and EQ-5D

Other outcomes

  1. Change from baseline regarding prescription of inappropriate medications in the intervention group

    Time frame: baseline and 6 months

    Improvement of polypharmacy

  2. Change from baseline in Morisky medication adherence scale and visual adherence scale

    Time frame: baseline

    Difference between Morisky medication scale score and score from the Visual adherence score

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 23, 2015
Registry last updated
Sep 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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