AdherenceNCT02424786
Non-adherence and Polypharmacy in Elderly Patients
A study testing STOPP/START criteria in people with Adherence, run by University Hospital, Akershus at 3 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Adherence
- What is being tested?
- STOPP/START criteria
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesNorway
- Study dates
- May 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- All patients > 65 years with CKD, stage 5 (eGFR ≤ 12 ml/min), or undergoing treatment with hemodialysis and peritoneal dialysis
Who cannot join
- Patients not willing to participate
- Patients diagnosed with dementia or severe cognitive disorder (MMS < 25),
- Patients with hearing impairment
- Patients with language difficulties
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Vestre Viken Sykehus
Drammen, 3004
University Hospital, Ullevål
Oslo, 0494
University Hospital, Akershus
Oslo, 1478
About this study
Official title: 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.
Read the 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.
- Conditions
- Adherence
- Being tested
- STOPP/START criteria
- Keywords
- Adherence, Polypharmacy, Elderly, Chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOPP/START criteriaOther
Evaluation of medication lists
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: STOPP/START criteria |
| Control | No intervention | Patients in this arm will receive standard pharmacological treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence for medication non-adherence
Adherence measured by Morisky medication adherence scale and visual adherence scale
Measured: 6 months - 1 year
Secondary outcomes (7)
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
Measured: 1-2 year
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
Measured: 1-2 year
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)
Measured: 1-2 years
Predictors for medication non-adherence
Questionnaires about depression and anxiety (HADS)
Measured: 6 months - 1 year
Risk factors for medication non-adherence
Questionnaires about beliefs about medicine
Measured: 6 months - 1 year
Medication non-adherence risk factors
Questionnaires about sleep quality (Epworth, Berlin, Pittsburgh questionnaires)
Measured: 6 months - 1 year
Non-adherence and medication - predictors
Questionnaires about quality of life measured by KDQOL-Short form 36 and EQ-5D
Measured: 6 months - 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krystina Parker, University Hospital, Akershus
- Investigators
- Knut Stavem, Professor, Principal investigator, University Hospital, AkershusIngrid Os, Principal investigator, Univeristy Hospital, Ullevål
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424786
- Sponsor's protocol ID
- 15-068
- Status last verified
- Sep 2017
- First submitted
- 31 Mar 2015
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No data will be shared
Publications
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.
PubMed 31359099
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-adherence and Polypharmacy in Elderly Patients With Chronic Renal Failure: Predictors and an Intervention
- ClinicalTrials.gov ID
- NCT02424786
- Acronym / sponsor ID
- 15-068
- Conditions
- Adherence
- Keywords
- Adherence, Polypharmacy, Elderly, Chronic kidney disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Other: STOPP/START criteriaMedication 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. |
| Control | No intervention | –Patients in this arm will receive standard pharmacological treatment |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- All patients > 65 years with CKD, stage 5 (eGFR ≤ 12 ml/min), or undergoing treatment with hemodialysis and peritoneal dialysis
Key exclusion criteria (4 listed)
- Patients not willing to participate
- Patients diagnosed with dementia or severe cognitive disorder (MMS < 25),
- Patients with hearing impairment
- Patients with language difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STOPP/START criteriaEvaluation of medication lists | Other | Intervention group |
Primary outcome
Prevalence for medication non-adherence
Time frame: 6 months - 1 year
Adherence measured by Morisky medication adherence scale and visual adherence scale
7 secondary outcomes
Improvement of polypharmacy
Time frame: 1-2 year
Improvement of adherence
Time frame: 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
Predictors for medication non-adherence
Time frame: 6 months - 1 year
Risk factors for medication non-adherence
Time frame: 6 months - 1 year
Medication non-adherence risk factors
Time frame: 6 months - 1 year
Non-adherence and medication - predictors
Time frame: 6 months - 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Derived from this study: PubMed 31359099Parker 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.
- Individual participant dataSharing planned: No. No data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Knut Stavem, Professor principal investigator
University Hospital, Akershus
Ingrid Os principal investigator
Univeristy Hospital, Ullevål
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STOPP/START criteria in people with Adherence, run by University Hospital, Akershus at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence for medication non-adherence (time frame: 6 months - 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02424786, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2017.