Medication AdherenceNCT03627338
Medication Adherence in Patients With Liver Cirrhosis
An observational study of Medication Adherence, run by Hannover Medical School at 1 site in Germany.
Trial summary
With this unfunded, investigator-initiated prospective, observational, explorative, single-arm and diagnostic single-centre study the investigators aim to evaluate medication adherence in patients with advanced liver cirrhosis Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Medication Adherence
- What is being tested?
- questionaire, interview
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2018to 31 May 2021
- Phase
- Observational
- 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 18 to 99 years
- All sexes
- Adult, Older adult
Study population: In addition to inclusion criteria: Treatment with Norfloxacin, Non-selective beta blockers and/or diuretics
Who may be able to join
- Treatment at Dept. of Gastroenterology, Hepatology and Endocrinology at Med. School of Hannover
- Liver cirrhosis
- Written consent for the use of personal data and health data for the purpose of this study
Who cannot join
- lack of written consent
- No consent ability
- Lack of literacy
- Inadequate knowledge of German language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medikamentenadhärenz Bei Patientinnen Und Patienten Mit Leberzirrhose
With this unfunded, investigator-initiated prospective, observational, explorative, single-arm and diagnostic single-centre study the investigators aim to evaluate medication adherence in patients with advanced liver cirrhosis
Read the detailed description
The main objective of the study is to investigate drug adherence in cirrhotic patients and to gain a better understanding of the causes of deficient adherence including evaluation for medication beliefs, satisfaction, depression, anxiety and health-related quality of life. A number of long-term medications have been approved for this group of patients in various indications and / or recommended by guidelines. However, adherence has not been adequately investigated yet. The investigators aim to focus on the following groups of ingredients / classes:
- Primary and secondary antibiotic prophylaxis (e.g. Norfloxacin)
- Non-selective beta-blockers (e.g. Carvedilol and Propranolol)
- diuretics (Spirolactones [e.g. Spironolacton], loop diuretics) Methodically, this is will be investigated in particular by taking into account the patients history, standardized questionnaires and validated interviews.
- Conditions
- Medication Adherence
- Being tested
- questionaire, interview
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionaire, interviewDiagnostic test
questionaire, interview
| Study group | Role | What they receive |
|---|---|---|
| Norfloxacin | evaluate medication adherence, patient history, medication beliefs and medication satisfaction, depression, anxiety and health-related quality of life Receives: Diagnostic Test: questionaire, interview | |
| Non-selective beta blockers | evaluate medication adherence, patient history, medication beliefs and medication satisfaction, depression, anxiety and health-related quality of life Receives: Diagnostic Test: questionaire, interview | |
| diuretics | evaluate medication adherence, patient history, medication beliefs and medication satisfaction, depression, anxiety and health-related quality of life Receives: Diagnostic Test: questionaire, interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence with BAASIS
Medication adherence will be investigated by using the BAASIS interview ((Basel Assessment of Adherence with Immunosuppressive Medication Scale)) The investigators use a validated German version of this instruments. Adherence is classified by means of a reliable rating system. For the BAASIS: Any YES on any of the questions 1a, 1B, 2 or 3 indicates an issue with implementation."YES" on item 4 indicates non-persistence of medication use. For the BAASIS the Overall can be quantified with both ways: as a dichtomus variable or as a continuous variable. The dichotomous variable of the BAASIS will use the scores on the questions assessing implementation and persistence (Questions 1a, 1b, 2, 3 and 4). The continuous variable will use a Visual Analogue Scale (VAS) assessing overall medication adherence over the last 4 weeks with higher scores represent higher perceived overall adherence.
Measured: One-point first visit, cross-section-designed study during the 24 month study period
Medication adherence with MARS
Medication adherence will be investigated by using the MARS ("Medication Adherence Report Scale" ) questionnaire (self-report). The investigators use a validated German version of this instruments. Adherence is classified by means of a reliable rating system. This 5-items scale asks respondents to rate the frequency with which they engage in each of 5 aspects of non-adherent behaviour Eg deciding to miss a dose, forgetting to take a dose), rated on a five point scale (where 5=never, 4 = rarely, 3 = sometimes, 2 = often and 1= very often). Scores for each of the 5 items were summed to give a scale score ranging from 5 to 25, where higher scores indicate higher levels of reported adherence.
Adherence can be expressed as a continuous scale, or by separating into 'high' and 'low' adherence groups on the basis of scale scores.
Measured: One-point first visit, cross-section-designed study during the 24 month study period
Secondary outcomes (7)
Medication satisfaction
Medication satisfactions is evaluated by using a self-report validated 19-item questionnaire ; the SIMS-D ("Satisfaction with Information about Medicines Scale"). Mediaction satisfaction is classified by means of a reliable rating system.
Measured: One-point first visit, cross-section-designed study during the 24 month study period
Medication belief
The investigators will use the "Beliefs about Medicines Questionnaire" (BMQ) as reliable survey tool for recording drug-related beliefs and perceptions of their benefits and / or harms. For this projects the investigators will use most recent German version authored by Nestoriuc et al. The BMQ is divided into a general and a drug-specific section. Medication belief is classified by means of a reliable rating system.
Measured: One-point first visit, cross-section-designed study during the 24 month study period
Depression
Depression will be evaluated by another self-reported instrument, the "Patient Health Questionnaire" (PHQ 9), which is a screening tool for depression disorders with a sufficient reliability. Depression is classified by means of a reliable rating system.
Measured: One-point first visit, cross-section-designed study during the 24 month study period
Anxiety
The investigators will use GAD 7 ("Generalized Anxiety Disorder Screeners"), another questionnaire, to screen for general anxiety disorders. This refers to the last 2 weeks and covers the most important clinical criteria according to DSM-IV. Anxiety is classified by means of a reliable rating system.
Measured: One-point first visit, cross-section-designed study during the 24 month study period
health-related Quality of Life
In addition, the investigators will use the CLDQ "Chronic Liver Disease Questionnaire" to examine the health-related quality of life in patients with hepatopathy regardless of severity or aetiology with high reliability. HRQoL is classified by means of a reliable rating system. The scale values of the subject are obtained by assigning 1 (always), 2 (mostly), 3 (common), 4 (repeated), 5 (sometimes), 6 (rare) and 7 (never)points. The values of the subscales of the original version are obtained by adding the items of the respective scale on the CLDQ-D evaluation sheet. The range of possible values per scale is between 1 and 7. Normative values of a representative population sample are not available. For comparison, the results of clinical trials can be used. Low values mean a reduced, high values a good health-related quality of life
Measured: One-point first visit, cross-section-designed study during the 24 month study period
Medication knowledge
At last, the investigators will evaluate the participant knowledge about their medication by using a self-constructed questionnaire. For this purpose we constructed an own Rating System.
Measured: One-point first visit, cross-section-designed study during the 24 month study period
Sociodemographic data
Sociodemographic data (e.g. age, education, income) will be collected with another self-constructed questionnaire in addition to already collected data of patients history from the disease record
Measured: One-point first visit, cross-section-designed study during the 24 month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start1 Sep 2018
- Primary completion31 Mar 2021 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Maasoumy, Associate Professor, MD, Principal investigator, Medical School of Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627338
- Sponsor's protocol ID
- HannoverGAS-Adhaerenzprojekt
- Status last verified
- Mar 2020
- First submitted
- 26 Jul 2018
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medikamentenadhärenz Bei Patientinnen Und Patienten Mit Leberzirrhose
- ClinicalTrials.gov ID
- NCT03627338
- Acronym / sponsor ID
- HannoverGAS-Adhaerenzprojekt
- Conditions
- Medication Adherence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 13 Aug 2018 (actual)
- 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.
With this unfunded, investigator-initiated prospective, observational, explorative, single-arm and diagnostic single-centre study the investigators aim to evaluate medication adherence in patients with advanced liver cirrhosis
Detailed description
The main objective of the study is to investigate drug adherence in cirrhotic patients and to gain a better understanding of the causes of deficient adherence including evaluation for medication beliefs, satisfaction, depression, anxiety and health-related quality of life. A number of long-term medications have been approved for this group of patients in various indications and / or recommended by guidelines. However, adherence has not been adequately investigated yet. The investigators aim to focus on the following groups of ingredients / classes:
- Primary and secondary antibiotic prophylaxis (e.g. Norfloxacin)
- Non-selective beta-blockers (e.g. Carvedilol and Propranolol)
- diuretics (Spirolactones [e.g. Spironolacton], loop diuretics) Methodically, this is will be investigated in particular by taking into account the patients history, standardized questionnaires and validated interviews.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Norfloxacin | – | Diagnostic Test: questionaire, interviewevaluate medication adherence, patient history, medication beliefs and medication satisfaction, depression, anxiety and health-related quality of life |
| Non-selective beta blockers | – | Diagnostic Test: questionaire, interviewevaluate medication adherence, patient history, medication beliefs and medication satisfaction, depression, anxiety and health-related quality of life |
| diuretics | – | Diagnostic Test: questionaire, interviewevaluate medication adherence, patient history, medication beliefs and medication satisfaction, depression, anxiety and health-related quality of life |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- In addition to inclusion criteria: Treatment with Norfloxacin, Non-selective beta blockers and/or diuretics
Key inclusion criteria (3 listed)
- Treatment at Dept. of Gastroenterology, Hepatology and Endocrinology at Med. School of Hannover
- Liver cirrhosis
- Written consent for the use of personal data and health data for the purpose of this study
Key exclusion criteria (4 listed)
- lack of written consent
- No consent ability
- Lack of literacy
- Inadequate knowledge of German language
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 |
|---|---|---|
| questionaire, interviewquestionaire, interview | Diagnostic test | Non-selective beta blockers, Norfloxacin, diuretics |
Primary outcome
Medication adherence with BAASIS
Time frame: One-point first visit, cross-section-designed study during the 24 month study period
Medication adherence will be investigated by using the BAASIS interview ((Basel Assessment of Adherence with Immunosuppressive Medication Scale)) The investigators use a validated German version of this instruments. Adherence is classified by means of a reliable rating system. For the BAASIS: Any YES on any of the questions 1a, 1B, 2 or 3 indicates an issue with implementation."YES" on item 4 indicates non-persistence of medication use. For the BAASIS the Overall can be quantified with both ways: as a dichtomus variable or as a continuous variable. The dichotomous variable of the BAASIS will use the scores on the questions assessing implementation and persistence (Questions 1a, 1b, 2, 3 and 4). The continuous variable will use a Visual Analogue Scale (VAS) assessing overall medication adherence over the last 4 weeks with higher scores represent higher perceived overall adherence.
Medication adherence with MARS
Time frame: One-point first visit, cross-section-designed study during the 24 month study period
Medication adherence will be investigated by using the MARS ("Medication Adherence Report Scale" ) questionnaire (self-report). The investigators use a validated German version of this instruments. Adherence is classified by means of a reliable rating system. This 5-items scale asks respondents to rate the frequency with which they engage in each of 5 aspects of non-adherent behaviour Eg deciding to miss a dose, forgetting to take a dose), rated on a five point scale (where 5=never, 4 = rarely, 3 = sometimes, 2 = often and 1= very often). Scores for each of the 5 items were summed to give a scale score ranging from 5 to 25, where higher scores indicate higher levels of reported adherence. Adherence can be expressed as a continuous scale, or by separating into 'high' and 'low' adherence groups on the basis of scale scores.
7 secondary outcomes
Medication satisfaction
Time frame: One-point first visit, cross-section-designed study during the 24 month study period
Medication belief
Time frame: One-point first visit, cross-section-designed study during the 24 month study period
Depression
Time frame: One-point first visit, cross-section-designed study during the 24 month study period
Anxiety
Time frame: One-point first visit, cross-section-designed study during the 24 month study period
health-related Quality of Life
Time frame: One-point first visit, cross-section-designed study during the 24 month study period
Medication knowledge
Time frame: One-point first visit, cross-section-designed study during the 24 month study period
Sociodemographic data
Time frame: One-point first visit, cross-section-designed study during the 24 month study period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
Benjamin Maasoumy, Associate Professor, MD principal investigator
Medical School of Hannover
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Adherence, run by Hannover Medical School at 1 site in Germany.
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 3 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: status not confirmed, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
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?
Medication adherence with BAASIS (time frame: One-point first visit, cross-section-designed study during the 24 month study period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2020.