Asthmagp-multitoolNCT06061172
Digital Tool Enhancing GPs' Information Management for Patients with Multimorbidity - a Pilot Study
A study testing gp-multitool.de in people with Asthma and Breast Neoplasms, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The gp-multitool.de study is a cluster-randomized controlled trial that aims to enhance evidence-based and patient-centered care for patients with multimorbidity by assessing and providing information relevant for the primary care of this patient group. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Asthma, Breast Neoplasms, Coronary Disease
- What is being tested?
- gp-multitool.de
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteGermany
- Study dates
- 2 Oct 2023to 29 Aug 2024
- 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
- participation in a 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, and chronic obstructive pulmonary disease
- 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/COPD, Gynaecological problems, Atherosclerosis/PAOD, 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/GERD, 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
- no access to a personal device with access to the internet (i.e., smartphone, tablet or personal computer)
- participation in other trials during the observation time of the pilot study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Digital Tool Enhancing GPs' Information Management in the Treatment of Patients with Multimorbidity - a Pilot Study (gp-multitool)
The gp-multitool.de study is a cluster-randomized controlled trial that aims to enhance evidence-based and patient-centered care for patients with multimorbidity by assessing and providing information relevant for the primary care of this patient group. This pilot study examines the feasibility of the gp-multitool.de study, i.e., intervention and evaluation in GP practices in urban and rural administrative districts in Germany.
Read the detailed description
The gp-multitool.de study is a cluster-randomized controlled trial that 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. It aims to reduce the time patients spend in hospital (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 controlled pilot study examines the feasibility of the gp-multitool.de study, i.e., intervention and evaluation in GP practices. Specifically, the aims of the pilot study are 1. to pilot the gp-multitool.de intervention over six months and to test acceptance, functionality, reliability and usability in general practices under real world conditions, 2. to assess feasibility of the study design, i.e., recruitment of practices and patients, baseline data acquisition, randomization, implementation of the intervention, and outcome data acquisition, and 3. to provide data for the final sample size calculation of the evaluation study.
GPs in the intervention group receive access to the digital tool, together with a brief introduction to its functionalities, a written manual, and contact data of a telephone support hotline, which can be called in case of any technical or organizational problems in relation to the digital tool. 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 gp-multitool.de 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 negative-binomial regression model, and secondary outcomes will be analyzed by multilevel mixed-effects linear and negative-binomial regression models.
In addition to quantitative data collection, a qualitative process evaluation with all participating GPs and one patient from each practice will be conducted based on a pre-defined semi-structured interview guide. The process evaluation will focus on compliance with the study protocol, problems with functionality, usability and reliability of the tool and possible sources of bias in the study. The interviews will be digitally recorded, transcribed verbatim and analyzed by qualitative content analysis.
- Conditions
- Asthma, Breast Neoplasms, Coronary Disease, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Pulmonary Disease, Chronic Obstructive
- Being tested
- gp-multitool.de
- Medical subject headings
- Asthma, Breast Neoplasms, Coronary Disease, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Pulmonary Disease, Chronic Obstructive
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 a digital tool, which implements recommendations of the S3 guideline "multimorbidity" of the German College of General Practitioners and Family Physicians. The tool includes nine questionnaires addressing four dimensions of care:
- preferences (including a. treatment goals, and b. involvement of other persons in decision making);
- activities (including a. activities and participation, and b. social support);
- treatment (including a. problems with medication, and b. treatment burden);
- complaints (including a. pain, b. psychiatric disorders, and c. other complaints).
The GPs can send the questionnaires by email to the patients and the patients can fill out the questionnaires at their home or in the waiting room of the GP's practice using their own smartphones, tablets or computers. The digital tool also includes instructions for conducting a medication review. Results from talks between GPs and patients can be documented in the tool.
| 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 for every patient at least twice (i.e., at least once a quarter), and have to use at least four specific questionnaires at least once, i.e. 1a is required, 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 is obligatory. Receives: Other: gp-multitool.de |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent in hospital during the preceding six months
The outcome will be assessed by asking the patients how often they had been in hospital during the preceding six months and how many days each hospital stay lasted. The total time in hospital will be calculated by adding the duration of all stays together.
Measured: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Secondary outcomes (9)
The number of contacts with the GP during the preceding six months
The outcome will be assessed by asking the patients how often they had used their GP during the preceding six 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 six months
The outcome will be assessed by asking the patients how often they had used outpatient specialists during the preceding six months.
Measured: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
The number of contacts with home care services during the preceding six months
The outcome will be assessed by asking the patients how often they had used home care services during the preceding six months.
Measured: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Process 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 six 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, 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)
Process 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 six 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 "EuroQoL five dimension five level scale" descriptive system, German value set
The outcome will be assessed by the "EuroQoL five dimension five level scale" (EQ-5D-5L) descriptive system (Herdman M et al. 2011, DOI: 10.1007/s11136-011-9903-x). A summary score will be calculated using the German value set (Ludwig K et al. 2018, DOI: 10.1007/s40273-018-0615-8). According to the German value set, the EQ-5D descriptive system has a possible range between 1.0 and -0.661 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 organization of care as assessed by the European Task Force on Patient Evaluation of General Practice Care questionnaire
The outcome will be assessed by subscale 'organization of care' of the European Task Force on Patient Evaluation of General Practice Care questionnaire (EUROPEP, Wensing M et al. 2000, DOI: https://doi.org/10.3109/13814780009069953). The score has a possible range between 0 and 4 points each and higher values indicate higher patient satisfaction.
Measured: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Patient satisfaction with clinical performance as assessed by the European Task Force on Patient Evaluation of General Practice Care questionnaire
The outcome will be assessed by subscale 'clinical performance' of the European Task Force on Patient Evaluation of General Practice Care questionnaire (EUROPEP, Wensing M et al. 2000, DOI: https://doi.org/10.3109/13814780009069953). The score has a possible range between 0 and 4 points each and higher values indicate higher patient satisfaction.
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 posted29 Sep 2023
- Study start2 Oct 2023
- Primary completion29 Aug 2024
- Study completion29 Aug 2024
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 AsthmaStudies 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
- Model description
- Participants are assigned to intervention group and control group, respectively, in parallel for the duration of the study
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingmar Schäfer, PD Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061172
- Sponsor's protocol ID
- 2022-100786-BO-ff
- Acronym
- gp-multitool
- Status last verified
- Dec 2023
- First submitted
- 8 Sep 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data are available from the principal investigator upon reasonable request.
Publications
Nothacker J, Paucke V, Lezius S, Zapf A, Luhmann D, Scherer M, Schafer I. Implementation of the German Clinical Practice Guideline for Multimorbidity Using a Digital Tool in Primary Care: Pilot Cluster Randomized Clinical Trial. JMIR Aging. 2025 Nov 20;8:e79767. doi: 10.2196/79767.
PubMed 41263476
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Digital Tool Enhancing GPs' Information Management in the Treatment of Patients with Multimorbidity - a Pilot Study (gp-multitool)
- ClinicalTrials.gov ID
- NCT06061172
- Acronym / sponsor ID
- gp-multitool / 2022-100786-BO-ff
- Conditions
- Asthma, Breast Neoplasms, Coronary Disease, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 29 Sep 2023 (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 gp-multitool.de study is a cluster-randomized controlled trial that aims to enhance evidence-based and patient-centered care for patients with multimorbidity by assessing and providing information relevant for the primary care of this patient group. This pilot study examines the feasibility of the gp-multitool.de study, i.e., intervention and evaluation in GP practices in urban and rural administrative districts in Germany.
Detailed description
The gp-multitool.de study is a cluster-randomized controlled trial that 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. It aims to reduce the time patients spend in hospital (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 controlled pilot study examines the feasibility of the gp-multitool.de study, i.e., intervention and evaluation in GP practices. Specifically, the aims of the pilot study are 1. to pilot the gp-multitool.de intervention over six months and to test acceptance, functionality, reliability and usability in general practices under real world conditions, 2. to assess feasibility of the study design, i.e., recruitment of practices and patients, baseline data acquisition, randomization, implementation of the intervention, and outcome data acquisition, and 3. to provide data for the final sample size calculation of the evaluation study.
GPs in the intervention group receive access to the digital tool, together with a brief introduction to its functionalities, a written manual, and contact data of a telephone support hotline, which can be called in case of any technical or organizational problems in relation to the digital tool. 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 gp-multitool.de 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 negative-binomial regression model, and secondary outcomes will be analyzed by multilevel mixed-effects linear and negative-binomial regression models.
In addition to quantitative data collection, a qualitative process evaluation with all participating GPs and one patient from each practice will be conducted based on a pre-defined semi-structured interview guide. The process evaluation will focus on compliance with the study protocol, problems with functionality, usability and reliability of the tool and possible sources of bias in the study. The interviews will be digitally recorded, transcribed verbatim and analyzed by qualitative content analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to intervention group and control group, respectively, in parallel for the duration of the study
| 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 for every patient at least twice (i.e., at least once a quarter), and have to use at least four specific questionnaires at least once, i.e. 1a is required, 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 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 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, and chronic obstructive pulmonary disease
- 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/COPD, Gynaecological problems, Atherosclerosis/PAOD, 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/GERD, Sexual dysfunction, Insomnia, Tobacco abuse, Hypotension
Key exclusion criteria (6 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
- no access to a personal device with access to the internet (i.e., smartphone, tablet or personal computer)
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 a digital tool, which implements recommendations of the S3 guideline "multimorbidity" of the German College of General Practitioners and Family Physicians. The tool includes nine questionnaires addressing four dimensions of care: 1. preferences (including a. treatment goals, and b. involvement of other persons in decision making); 2. activities (including a. activities and participation, and b. social support); 3. treatment (including a. problems with medication, and b. treatment burden); 4. complaints (including a. pain, b. psychiatric disorders, and c. other complaints). The GPs can send the questionnaires by email to the patients and the patients can fill out the questionnaires at their home or in the waiting room of the GP's practice using their own smartphones, tablets or computers. The digital tool also includes instructions for conducting a medication review. Results from talks between GPs and patients can be documented in the tool. | Other | Intervention group |
Primary outcome
Time spent in hospital during the preceding six 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 asking the patients how often they had been in hospital during the preceding six months and how many days each hospital stay lasted. The total time in hospital will be calculated by adding the duration of all stays together.
9 secondary outcomes
The number of contacts with the GP during the preceding six 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 six months
Time frame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
The number of contacts with home care services during the preceding six months
Time frame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Process 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 six months
Time frame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Process 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 six 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 "EuroQoL five dimension five level scale" descriptive system, German value set
Time frame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Patient satisfaction with organization of care as assessed by the European Task Force on Patient Evaluation of General Practice Care questionnaire
Time frame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Patient satisfaction with clinical performance as assessed by the European Task Force on Patient Evaluation of General Practice Care questionnaire
Time frame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
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 12 Dec 2024.
- Derived from this study: PubMed 41263476Nothacker J, Paucke V, Lezius S, Zapf A, Luhmann D, Scherer M, Schafer I. Implementation of the German Clinical Practice Guideline for Multimorbidity Using a Digital Tool in Primary Care: Pilot Cluster Randomized Clinical Trial. JMIR Aging. 2025 Nov 20;8:e79767. doi: 10.2196/79767.
- Individual participant dataSharing planned: Yes. Individual participant data are available from the principal investigator upon reasonable request.
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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, PD 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 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 6 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 12 Dec 2024. 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?
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?
Time spent in hospital during the preceding six 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 NCT06061172, 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 12 Dec 2024.