DiabetesPhase 4NCT01587599
Pharmaceutical Care of Patients With Impaired Mobility in a Model-region of Decreasing Supply of Medical Services
A Phase 4 study testing counseling in people with Diabetes, run by Foerderinitiative Pharmazeutische Betreuung e.V..
Trial summary
Design and Procedure: The design is a randomised controlled multi-centre pilot study. 18 community pharmacies located in Mecklenburg-Western Pomerania, Germany, were randomised to either a control or an intervention group. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Mar 2013
- Phase
- Phase 4
- 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
- impairment in mobility
- age of 65 years or older
- four or more long-term medications
- diabetes
- at least one of the following co-morbidities: hypertension, obesity, hypercholesteremia, hyperlipidemia, coronary heart disease, cardiac insufficiency, angina pectoris, peripheral vascular disease
Who cannot join
- patient lives in a home for the aged or a residential care home for the elderly
- terminal renal failure, dialysis
- moderately or severe dementia or other severe cognitive impairments
- terminal diseases (e.g. cancer)
- nursing service if the medicine is directly administered to the patient
About this study
Official title: Pharmaceutical Care of Elderly Diabetes-patients With Impaired Mobility in a Model-region of Decreasing Supply of Medical Services in North-eastern Germany
Design and Procedure:
The design is a randomised controlled multi-centre pilot study. 18 community pharmacies located in Mecklenburg-Western Pomerania, Germany, were randomised to either a control or an intervention group. These pharmacies recruited eligible patients out of their clientele and invited them to take part in the study. Participants were visited at home by the pharmacist and home-based medication reviews were conducted. The survey form has been developed by the research team and comprised amongst others items to adherence, adverse effects, drug intake, storage and quality of life. Thereafter all data were analysed by the pharmacist with a newly developed document called "analysis guide" aiming at the detection of drug related problems. Pharmacists of the intervention group discussed the results with the family doctor of the patients and the patients and tried to solve the drug related problems. This procedure was not undertaken in the control group.
Read more
Six months later a second medication review was carried out in both groups.
Study hypothesis:
Pharmaceutical care reduces the overall number of drug-related problems of elderly patients with diabetes and impairments in mobility.
Aim:
The purpose of this study is to show that pharmaceutical care reduces the overall number of drug-related problems of elderly diabetes-patients with impairments in mobility and leads to both an improved health status and an improved quality of life.
- Conditions
- Diabetes
- Being tested
- counseling
- Keywords
- pharmaceutical care, drug-related problems, elderly, Pharmaceutical care of elderly patients with diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counselingBehavioural
The patients grouped to the intervention cohort receive pharmaceutical care by a pharmacist during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Pharmaceutical care | Active comparator | Not described Receives: Behavioral: counseling |
| Standard care | Placebo comparator | Not described Receives: Behavioral: counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence
MMAS-8d
Measured: 6 months
adverse events
SHIP-trend 8-items questionnaire
Measured: 6 months
drug-drug-interactions
ABDATA drug-drug interaction identification tool
Measured: 6 months
Secondary outcomes (2)
quality of life
improvement of quality of life, measured with eq-5d
Measured: 6 months
improved overall health status
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startJun 2010
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foerderinitiative Pharmazeutische Betreuung e.V.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Christoph Ritter, Foerderinitiative Pharmazeutische Betreuung e.V.
- Investigators
- Christoph A Ritter, Prof. Dr., Principal investigator, Ernst-Moritz-Arndt-University Greifswald, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587599
- Sponsor's protocol ID
- FI_CLIN_PHARM_EMAU_01
- Status last verified
- Apr 2012
- First submitted
- 25 Apr 2012
- Last updated
- 30 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmaceutical Care of Elderly Diabetes-patients With Impaired Mobility in a Model-region of Decreasing Supply of Medical Services in North-eastern Germany
- ClinicalTrials.gov ID
- NCT01587599
- Acronym / sponsor ID
- FI_CLIN_PHARM_EMAU_01
- Conditions
- Diabetes
- Keywords
- pharmaceutical care, drug-related problems, elderly, Pharmaceutical care of elderly patients with diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Foerderinitiative Pharmazeutische Betreuung e.V.University, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 30 Apr 2012 (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.
Design and Procedure:
The design is a randomised controlled multi-centre pilot study. 18 community pharmacies located in Mecklenburg-Western Pomerania, Germany, were randomised to either a control or an intervention group. These pharmacies recruited eligible patients out of their clientele and invited them to take part in the study. Participants were visited at home by the pharmacist and home-based medication reviews were conducted. The survey form has been developed by the research team and comprised amongst others items to adherence, adverse effects, drug intake, storage and quality of life. Thereafter all data were analysed by the pharmacist with a newly developed document called "analysis guide" aiming at the detection of drug related problems. Pharmacists of the intervention group discussed the results with the family doctor of the patients and the patients and tried to solve the drug related problems. This procedure was not undertaken in the control group.
Six months later a second medication review was carried out in both groups.
Study hypothesis:
Pharmaceutical care reduces the overall number of drug-related problems of elderly patients with diabetes and impairments in mobility.
Aim:
The purpose of this study is to show that pharmaceutical care reduces the overall number of drug-related problems of elderly diabetes-patients with impairments in mobility and leads to both an improved health status and an improved quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmaceutical care | Active comparator | Behavioral: counseling |
| Standard care | Placebo comparator | Behavioral: counseling |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- impairment in mobility
- age of 65 years or older
- four or more long-term medications
- diabetes
- at least one of the following co-morbidities: hypertension, obesity, hypercholesteremia, hyperlipidemia, coronary heart disease, cardiac insufficiency, angina pectoris, peripheral vascular disease
Key exclusion criteria (5 listed)
- patient lives in a home for the aged or a residential care home for the elderly
- terminal renal failure, dialysis
- moderately or severe dementia or other severe cognitive impairments
- terminal diseases (e.g. cancer)
- nursing service if the medicine is directly administered to the patient
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 |
|---|---|---|
| counselingThe patients grouped to the intervention cohort receive pharmaceutical care by a pharmacist during the study period. | Behavioural | Pharmaceutical care, Standard care |
Primary outcome
adherence
Time frame: 6 months
MMAS-8d
adverse events
Time frame: 6 months
SHIP-trend 8-items questionnaire
drug-drug-interactions
Time frame: 6 months
ABDATA drug-drug interaction identification tool
2 secondary outcomes
quality of life
Time frame: 6 months
improved overall health status
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
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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.
Christoph A Ritter, Prof. Dr. principal investigator
Ernst-Moritz-Arndt-University Greifswald, Germany
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing counseling in people with Diabetes, run by Foerderinitiative Pharmazeutische Betreuung e.V..
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 5 inclusion and 5 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 30 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
adherence (time frame: 6 months). The study lists 3 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 30 Apr 2012.