NCT02424786

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 20, 2017

Status Verified

September 1, 2017

Enrollment Period

2.3 years

First QC Date

March 31, 2015

Last Update Submit

September 19, 2017

Conditions

Adherence

Keywords

AdherencePolypharmacyElderlyChronic kidney disease

Outcome Measures

Primary Outcomes (1)

  • Prevalence for medication non-adherence

    Adherence measured by Morisky medication adherence scale and visual adherence scale

    6 months - 1 year

Secondary Outcomes (7)

  • Improvement of polypharmacy

    1-2 year

  • Improvement of adherence

    1-2 year

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

    1-2 years

  • Predictors for medication non-adherence

    6 months - 1 year

  • Risk factors for medication non-adherence

    6 months - 1 year

  • +2 more secondary outcomes

Other Outcomes (2)

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

    baseline and 6 months

  • Change from baseline in Morisky medication adherence scale and visual adherence scale

    baseline

Study Arms (2)

Intervention group

OTHER

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

Control

NO INTERVENTION

Patients in this arm will receive standard pharmacological treatment

Interventions

STOPP/START criteriaOTHER

Evaluation of medication lists

Intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • All patients \> 65 years with CKD, stage 5 (eGFR ≤ 12 ml/min), or undergoing treatment with hemodialysis and peritoneal dialysis

You may not qualify if:

  • Patients not willing to participate
  • Patients diagnosed with dementia or severe cognitive disorder (MMS \< 25),
  • Patients with hearing impairment
  • Patients with language difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Vestre Viken Sykehus

Drammen, 3004, Norway

Location

University Hospital, Ullevål

Oslo, 0494, Norway

Location

University Hospital, Akershus

Oslo, 1478, Norway

Location

Related Publications (1)

  • Parker K, Bull-Engelstad I, Benth JS, Aasebo W, von der Lippe N, Reier-Nilsen M, Os I, Stavem K. Effectiveness of using STOPP/START criteria to identify potentially inappropriate medication in people aged >/= 65 years with chronic kidney disease: a randomized clinical trial. Eur J Clin Pharmacol. 2019 Nov;75(11):1503-1511. doi: 10.1007/s00228-019-02727-9. Epub 2019 Jul 29.

    PMID: 31359099DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Potentially Inappropriate Medication List

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Knut Stavem, Professor

    University Hospital, Akershus

    PRINCIPAL INVESTIGATOR

  • Ingrid Os

    Univeristy Hospital, Ullevål

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, pHD-student

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 23, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

September 20, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

No data will be shared

Locations

NO(3)