Non-adherence and Polypharmacy in Elderly Patients

September 19, 2017 updated by: Krystina Parker, University Hospital, Akershus

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Drammen, Norway, 3004
        • Vestre Viken sykehus
      • Oslo, Norway, 0494
        • University Hospital, Ullevål
      • Oslo, Norway, 1478
        • University Hospital, Akershus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Intervention group

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.
Other: STOPP/START criteria
Evaluation of medication lists
No Intervention: Control
Patients in this arm will receive standard pharmacological treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevalence for medication non-adherence
Time Frame: 6 months - 1 year
Adherence measured by Morisky medication adherence scale and visual adherence scale
6 months - 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
1-2 year
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
1-2 year
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)
1-2 years
Predictors for medication non-adherence
Time Frame: 6 months - 1 year
Questionnaires about depression and anxiety (HADS)
6 months - 1 year
Risk factors for medication non-adherence
Time Frame: 6 months - 1 year
Questionnaires about beliefs about medicine
6 months - 1 year
Medication non-adherence risk factors
Time Frame: 6 months - 1 year
Questionnaires about sleep quality (Epworth, Berlin, Pittsburgh questionnaires)
6 months - 1 year
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
6 months - 1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline regarding prescription of inappropriate medications in the intervention group
Time Frame: baseline and 6 months
Improvement of polypharmacy
baseline and 6 months
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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Akershus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Knut Stavem, Professor, University Hospital, Akershus
  • Principal Investigator: Ingrid Os, Univeristy Hospital, Ullevål

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 20, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15-068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No data will be shared

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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