Asthma BronchialeNCT06831994
Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity
A study testing gp-multitool.de in people with Asthma Bronchiale and Breast Neoplasms, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The web application gp-multitool.de is a digital tool for implementing the German S3 clinical practice guideline for multimorbidity of the German Society of General Practitioners and Family Physicians in primary care. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Asthma Bronchiale, Breast Neoplasms, Coronary Disease
- What is being tested?
- gp-multitool.de
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 659 participants
- Where
- 1 siteGermany
- Study dates
- 26 Feb 2025to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- participation in a disease management program (DMP); in Germany, DMPs have been implemented in outpatient care for asthma, breast neoplasms, coronary heart disease, diabetes mellitus type 1, diabetes mellitus type 2, chronic obstructive pulmonary disease, obesity, heart failure, chronic low back pain, depression, osteoporosis, rheumatoid arthritis
- at least two of the following coexisting conditions: Hypertension, Lipid metabolism disorders, Chronic low back pain, Severe vision reduction, Joint arthrosis, Diabetes mellitus, Chronic ischemic heart disease, Thyroid dysfunction, Cardiac arrhythmias, Obesity, Hyperuricemia/Gout, Prostatic hyperplasia, Lower limb varicosis, Liver diseases, Depression, Asthma/Chronic obstructive pulmonary disease, Gynaecological problems, Atherosclerosis/Peripheral arterial occlusive disease, Osteoporosis, Renal insufficiency, Cerebral ischemia/Chronic stroke, Cardiac insufficiency, Severe hearing loss, Chronic cholecystitis/Gallstones, Somatoform disorders, Hemorrhoids, Intestinal diverticulosis, Rheumatoid arthritis/Chronic polyarthritis, Cardiac valve disorders, Neuropathies, Dizziness, Dementias, Urinary incontinence, Urinary tract calculi, Anemias, Anxiety, Psoriasis, Migraine/chronic headache, Parkinson's disease, Cancers, Allergies, Chronic gastritis/Gastroesophageal reflux disease, Sexual dysfunction, Insomnia, Tobacco abuse, Hypotension
Who cannot join
- no capacity to consent
- functional limitations precluding participation in the intervention (eg, loss of vision)
- functional limitations precluding participation in telephone interviews (eg, loss of hearing)
- limited German language skills precluding participation in telephone interviews
- participation in other trials during the observation time of the evaluation study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Implementation of the German S3 Clinical Practice Guideline for Primary Care of Older Patients With Multimorbidity - a Cluster-randomised Clinical Evaluation Study (Gp-multitool.de)
The web application gp-multitool.de is a digital tool for implementing the German S3 clinical practice guideline for multimorbidity of the German Society of General Practitioners and Family Physicians in primary care. The tool enhances evidence-based and patient-centered care by assessing and providing information relevant for the primary care of this patient group. This cluster-randomised clinical evaluation study examines the effectiveness of an intervention based on gp-multitool.de in general practitioner (GP) practices in Germany.
Read the detailed description
The web application gp-multitool.de study is a digital tool for implementing the German S3 clinical practice guideline for multimorbidity of the German Society of General Practitioners and Family Physicians in primary care. The tool enhances evidence-based and patient-centered care for patients with multimorbidity by assessing and providing information relevant for the primary care of this patient group. The study intervention is based on this digital tool and aims to reduce the probability of hospital admissions (primary outcome) and their outpatient health care use, and to improve process quality of care, patients' health-related quality of life, and patient satisfaction (secondary outcomes).
This cluster-randomized clinical evaluation study examines the effectiveness of the gp-multitool.de intervention in GP practices. GPs in the intervention group implement the intervention in consultations with participating patients for 12 months. Intervention GPs gain access to the digital tool, and get a brief introduction to its functionalities, a video tutorial, a written manual, and contact data of telephone support, which can be called in case of any technical or organizational problems in relation to the digital tool. In addition, they receive a short training in the intervention and a checklist of requirements defined in the study protocol. Moreover, each intervention practice will be provided with a mobile device, facilitating inclusion of patients without access to the internet. GPs in the control group receive no intervention and provide care as usual.
Patients will be recruited from GP practices in urban and rural administrative districts in Germany. The evaluation study is based on telephone interviews of patients and their GPs. Practices will be randomized after the baseline assessment by an independent statistician who does not have access to the assessed patient and practice data. The primary outcome will be analyzed using a multilevel mixed-effects logistic regression model, and secondary outcomes will be analyzed by multilevel mixed-effects linear and negative-binomial regression models. The project staff conducting patient interviews will be blinded regarding allocation of the patient's practices.
- Conditions
- Asthma Bronchiale, Breast Neoplasms, Coronary Disease, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Pulmonary Disease, Chronic Obstructive
- Being tested
- gp-multitool.de
- Medical subject headings
- Breast Neoplasms, Coronary Disease, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Pulmonary Disease, Chronic Obstructive, Obesity, Heart Failure, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gp-multitool.deOther
The intervention is based on the digital tool gp-multitool.de. The GPs can send questionnaires by email to patients and patients can fill out questionnaires at their home or in the waiting room of the practice using any digital device with browser and access to the internet. The digital tool also includes instructions for conducting a medication review. Results will be available from the computers of attending GPs. Decisions from talks between GPs and patients can be documented in the tool. The tool includes ten questionnaires:
- patient preferences (including a. treatment goals, and b. involvement of other persons in decision making);
- social life (including a. activities and participation, and b. social support);
- treatment situation (including a. problems with medication, and b. treatment burden);
- health complaints (including a. pain, b. psychiatric disorders, and c. other complaints).
- resilience and protective behavior against heat.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Care as usual |
| Intervention group | Experimental | GPs in the intervention arm have to use the web application gp-multitool.de. For every participating patient they have to use at least four specific questionnaires in the first six intervention months, i.e. 1a is required, and either 2a or 2b, and either 3a or 3b, and either 4a or 4b or 4c. In the following six intervention months, GPs in the intervention arm also have to use at least four specific questionnaires, i.e., 1a is required again, and either 2a or 2b, and either 3a or 3b, and either 4a or 4b or 4c. Results from the questionnaires need to be discussed between GPs and patients. Additionally, at least one medication review during the first six intervention months is obligatory. Receives: Other: gp-multitool.de |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether patients have stayed at least once for at least one night in hospital during the preceding twelve months
The outcome will be assessed by a standardised questionnaire. The patients will be asked how often they had been in hospital during the preceding twelve months and how long these stays had lasted. Before analysis, the outcome will be dichotomised.
Measured: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Secondary outcomes (7)
The number of contacts with the GP during the preceding twelve months
The outcome will be assessed by asking the patients how often they had visited their GP during the preceding twelve months.
Measured: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
The number of contacts with outpatient specialists during the preceding twelve months
The outcome will be assessed by asking the patients how often they had visited outpatient specialists during the preceding twelve months.
Measured: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Quality of care as assessed by the summary score of the "GP-reported core set of quality indicators for older adults with multimorbidity in primary care" during the preceding twelve months
The outcome will be assessed by the "GP-reported core set of quality indicators for older adults with multimorbidity in primary care" (Schäfer I et al. 2023, digital object identifier (DOI): https://doi.org/10.1186/s12916-023-02856-0), which has a possible range between 0 and 12 points. Higher scores indicate a better quality of primary care.
Measured: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Quality of care as assessed by the summary score of the "patient-reported core set of quality indicators for older adults with multimorbidity in primary care" during the preceding twelve months
The outcome will be assessed by the "Patient-reported core set of quality indicators for older adults with multimorbidity in primary care" (Schäfer I et al. 2023, DOI: https://doi.org/10.1186/s12916-023-02856-0), which has a possible range between 0 and 7 points. Higher scores indicate a better quality of primary care.
Measured: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Self-rated health as assessed by the EuroQoL visual analogue scale
The outcome will be assessed by the EuroQoL visual analogue scale (Herdman M et al. 2011, DOI: 10.1007/s11136-011-9903-x), which has a possible range between 0 and 100 points. Higher scores indicate a better self-rated health.
Measured: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Health-related quality of life as assessed by the "Short-Form-Health Survey (SF-12)" questionnaire
The outcome will be assessed by the "Short-Form-Health Survey (SF-12)" questionnaire (Wirtz M.A. et al. 2018, DOI: 10.1026/0012-1924/a000205), which has a possible range between 0 and 100 points. Higher scores indicate a better health-related quality of life.
Measured: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Patient satisfaction with chronic illness care assessed by the "Patient Assessment of Chronic Illness Care (PACIC 5A)" questionnaire
The outcome will be assessed by the "PACIC 5A" questionnaire (Rosemann T et al. 2007, DOI: 10.1111/j.1365-2753.2007.00786.x), which has a possible range between 1 and 5 points. Higher scores indicate a higher patient satisfaction with chronic illness care from patient's perspective.
Measured: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start26 Feb 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
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 Asthma BronchialeStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 659 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingmar Schäfer, Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831994
- Sponsor's protocol ID
- 01GY2109
- Status last verified
- May 2026
- First submitted
- 12 Feb 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be included in the publication as supplementary file.
Publications
Schafer I, Menzel A, Lezius S, Krause L, Zapf A, Luhmann D, Scherer M, Paucke V, Nothacker J. Effects of a digital tool implementing the German S3 clinical practice guideline for multimorbidity in primary care (gp-multitool.de): study protocol for a cluster-randomised controlled trial. BMJ Open. 2025 Aug 3;15(8):e102086. doi: 10.1136/bmjopen-2025-102086.
PubMed 40754332
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Implementation of the German S3 Clinical Practice Guideline for Primary Care of Older Patients With Multimorbidity - a Cluster-randomised Clinical Evaluation Study (Gp-multitool.de)
- ClinicalTrials.gov ID
- NCT06831994
- Acronym / sponsor ID
- 01GY2109
- Conditions
- Asthma Bronchiale, Breast Neoplasms, Coronary Disease, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 659 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 18 Feb 2025 (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.
The web application gp-multitool.de is a digital tool for implementing the German S3 clinical practice guideline for multimorbidity of the German Society of General Practitioners and Family Physicians in primary care. The tool enhances evidence-based and patient-centered care by assessing and providing information relevant for the primary care of this patient group. This cluster-randomised clinical evaluation study examines the effectiveness of an intervention based on gp-multitool.de in general practitioner (GP) practices in Germany.
Detailed description
The web application gp-multitool.de study is a digital tool for implementing the German S3 clinical practice guideline for multimorbidity of the German Society of General Practitioners and Family Physicians in primary care. The tool enhances evidence-based and patient-centered care for patients with multimorbidity by assessing and providing information relevant for the primary care of this patient group. The study intervention is based on this digital tool and aims to reduce the probability of hospital admissions (primary outcome) and their outpatient health care use, and to improve process quality of care, patients' health-related quality of life, and patient satisfaction (secondary outcomes).
This cluster-randomized clinical evaluation study examines the effectiveness of the gp-multitool.de intervention in GP practices. GPs in the intervention group implement the intervention in consultations with participating patients for 12 months. Intervention GPs gain access to the digital tool, and get a brief introduction to its functionalities, a video tutorial, a written manual, and contact data of telephone support, which can be called in case of any technical or organizational problems in relation to the digital tool. In addition, they receive a short training in the intervention and a checklist of requirements defined in the study protocol. Moreover, each intervention practice will be provided with a mobile device, facilitating inclusion of patients without access to the internet. GPs in the control group receive no intervention and provide care as usual.
Patients will be recruited from GP practices in urban and rural administrative districts in Germany. The evaluation study is based on telephone interviews of patients and their GPs. Practices will be randomized after the baseline assessment by an independent statistician who does not have access to the assessed patient and practice data. The primary outcome will be analyzed using a multilevel mixed-effects logistic regression model, and secondary outcomes will be analyzed by multilevel mixed-effects linear and negative-binomial regression models. The project staff conducting patient interviews will be blinded regarding allocation of the patient's practices.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Care as usual |
| Intervention group | Experimental | Other: gp-multitool.deGPs in the intervention arm have to use the web application gp-multitool.de. For every participating patient they have to use at least four specific questionnaires in the first six intervention months, i.e. 1a is required, and either 2a or 2b, and either 3a or 3b, and either 4a or 4b or 4c. In the following six intervention months, GPs in the intervention arm also have to use at least four specific questionnaires, i.e., 1a is required again, and either 2a or 2b, and either 3a or 3b, and either 4a or 4b or 4c. Results from the questionnaires need to be discussed between GPs and patients. Additionally, at least one medication review during the first six intervention months is obligatory. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- participation in a disease management program (DMP); in Germany, DMPs have been implemented in outpatient care for asthma, breast neoplasms, coronary heart disease, diabetes mellitus type 1, diabetes mellitus type 2, chronic obstructive pulmonary disease, obesity, heart failure, chronic low back pain, depression, osteoporosis, rheumatoid arthritis
- at least two of the following coexisting conditions: Hypertension, Lipid metabolism disorders, Chronic low back pain, Severe vision reduction, Joint arthrosis, Diabetes mellitus, Chronic ischemic heart disease, Thyroid dysfunction, Cardiac arrhythmias, Obesity, Hyperuricemia/Gout, Prostatic hyperplasia, Lower limb varicosis, Liver diseases, Depression, Asthma/Chronic obstructive pulmonary disease, Gynaecological problems, Atherosclerosis/Peripheral arterial occlusive disease, Osteoporosis, Renal insufficiency, Cerebral ischemia/Chronic stroke, Cardiac insufficiency, Severe hearing loss, Chronic cholecystitis/Gallstones, Somatoform disorders, Hemorrhoids, Intestinal diverticulosis, Rheumatoid arthritis/Chronic polyarthritis, Cardiac valve disorders, Neuropathies, Dizziness, Dementias, Urinary incontinence, Urinary tract calculi, Anemias, Anxiety, Psoriasis, Migraine/chronic headache, Parkinson's disease, Cancers, Allergies, Chronic gastritis/Gastroesophageal reflux disease, Sexual dysfunction, Insomnia, Tobacco abuse, Hypotension
Key exclusion criteria (5 listed)
- no capacity to consent
- functional limitations precluding participation in the intervention (eg, loss of vision)
- functional limitations precluding participation in telephone interviews (eg, loss of hearing)
- limited German language skills precluding participation in telephone interviews
- participation in other trials during the observation time of the evaluation study
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 |
|---|---|---|
| gp-multitool.deThe intervention is based on the digital tool gp-multitool.de. The GPs can send questionnaires by email to patients and patients can fill out questionnaires at their home or in the waiting room of the practice using any digital device with browser and access to the internet. The digital tool also includes instructions for conducting a medication review. Results will be available from the computers of attending GPs. Decisions from talks between GPs and patients can be documented in the tool. The tool includes ten questionnaires: 1. patient preferences (including a. treatment goals, and b. involvement of other persons in decision making); 2. social life (including a. activities and participation, and b. social support); 3. treatment situation (including a. problems with medication, and b. treatment burden); 4. health complaints (including a. pain, b. psychiatric disorders, and c. other complaints). 5. resilience and protective behavior against heat. | Other | Intervention group |
Primary outcome
Whether patients have stayed at least once for at least one night in hospital during the preceding twelve months
Time frame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
The outcome will be assessed by a standardised questionnaire. The patients will be asked how often they had been in hospital during the preceding twelve months and how long these stays had lasted. Before analysis, the outcome will be dichotomised.
7 secondary outcomes
The number of contacts with the GP during the preceding twelve months
Time frame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
The number of contacts with outpatient specialists during the preceding twelve months
Time frame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Quality of care as assessed by the summary score of the "GP-reported core set of quality indicators for older adults with multimorbidity in primary care" during the preceding twelve months
Time frame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Quality of care as assessed by the summary score of the "patient-reported core set of quality indicators for older adults with multimorbidity in primary care" during the preceding twelve months
Time frame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Self-rated health as assessed by the EuroQoL visual analogue scale
Time frame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Health-related quality of life as assessed by the "Short-Form-Health Survey (SF-12)" questionnaire
Time frame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Patient satisfaction with chronic illness care assessed by the "Patient Assessment of Chronic Illness Care (PACIC 5A)" questionnaire
Time frame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Derived from this study: PubMed 40754332Schafer I, Menzel A, Lezius S, Krause L, Zapf A, Luhmann D, Scherer M, Paucke V, Nothacker J. Effects of a digital tool implementing the German S3 clinical practice guideline for multimorbidity in primary care (gp-multitool.de): study protocol for a cluster-randomised controlled trial. BMJ Open. 2025 Aug 3;15(8):e102086. doi: 10.1136/bmjopen-2025-102086.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be included in the publication as supplementary file.
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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.
Ingmar Schäfer, Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gp-multitool.de in people with Asthma Bronchiale and Breast Neoplasms, run by Universitätsklinikum Hamburg-Eppendorf 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 2 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: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Whether patients have stayed at least once for at least one night in hospital during the preceding twelve months (time frame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)). 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 NCT06831994, 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 29 May 2026.