Utilization of Nursing, Medical and Therapeutical Care of People Living at Home With Care Needsinterprof HOMENCT05149937
Development and Testing of an Interprofessional, Person-centered Care Concept for People Living at Home With Care Needs.
A study testing interprofessional, person-centered care concept in people with Utilization of Nursing, Medical and Therapeutical Care of People Living at Home With Care Needs, run by University Medical Center Goettingen.
Trial summary
The aim of the project is to develop and pilot measures to optimize the person-centered cooperation between nursing services, general practitioners and members of the therapeutic professions in the care of people living at home with care needs, so that hospital admissions and the use of unplanned medical and rescue… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Utilization of Nursing, Medical and Therapeutical Care of People Living at Home With Care Needs
- What is being tested?
- interprofessional, person-centered care concept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 30 Sep 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- years of age >18
- receipt of benefits in the form of outpatient care according to SGB XI,
- preliminary / final classification of care ≥level 2
- expected life expectancy >6 months
- informed consent
- sufficient opportunity to answer answering questions about patient-reported outcomes
Who cannot join
- Living in nursing home / planned move-in within the following 6 months
- claim acceptance of SAPV
- participation in scientific study
About this study
The aim of the project is to develop and pilot measures to optimize the person-centered cooperation between nursing services, general practitioners and members of the therapeutic professions in the care of people living at home with care needs, so that hospital admissions and the use of unplanned medical and rescue services are avoided, the quality of life is improved and a deterioration in the need for long-term care can be stopped.
This is done by developing an interprofessional person-centered collaboration-concept, perform an explorative mixed-methods-study: interviews, focus groups, expert workshops, survey of best practices, shadowing, questionnaires.
Read the detailed description
Description of mixed-methods-study:
- Interviews with
- 20 patients,
- 20 relatives,
- 5 experts of health insurance professionals,
- and 3 focus groups à 8 persons with general practioniers, nurses, therapists.
- investigation of best practice cases
- explorative survey of 100 cases in each group:
- general practitioner
- nursing services
- therapists
- persons in need of care
- family members of persons in need of care
The mixed-methods-study is analysed in different ways:
- structured content analysis
- case-based qualitative analysis of interviews
- descriptive analysis
The mixed-methods-study has been approved by the ethics committee and is recruiting.
- Conditions
- Utilization of Nursing, Medical and Therapeutical Care of People Living at Home With Care Needs
- Being tested
- interprofessional, person-centered care concept
- Keywords
- interprofessional collaboration, reduction of hospitalisation, people living at home with care needs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interprofessional, person-centered care conceptOther
interprofessional, person-centered care concept
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Implementation of interprof Home measures to improve cooperation between nursing services, general practitioners and members of the therapeutic professions in the care of people living at home with care needs. Receives: Other: interprofessional, person-centered care concept |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative number of hospitalisation
Cumulative incidence of hospitalisations within 12 months
Measured: 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Jan 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Why it stopped: Study stopped before first patient inclusion. Mixed-methods-study (part a) completed per protocol, explorative survey (part b) withdrawn due to organizational reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Utilization of Nursing, Medical and Therapeutical Care of People Living at Home With Care NeedsStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karsten Gavenis, University Medical Center Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149937
- Sponsor's protocol ID
- 2020-00425
- Acronym
- interprof HOME
- Status last verified
- Oct 2023
- First submitted
- 3 Nov 2021
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tetzlaff B, Mazur AL, Sekanina U, Huckle T, Dano R, Hockelmann C, Diel M, Bremer L, Kuhn A, Romanski AM, Kuba S, Ruppel T, Balzer K, Kopke S, Maurer I, Weber CE, Scherer M, Hummers E, Muller CA. Development of an interprofessional person-centred care concept for persons with care needs living in their own homes in Germany (interprof HOME): a mixed methods study. BMC Prim Care. 2025 Nov 15;26(1):363. doi: 10.1186/s12875-025-03098-0.
PubMed 41241758Sekanina U, Tetzlaff B, Mazur A, Huckle T, Kuhn A, Dano R, Hockelmann C, Scherer M, Balzer K, Kopke S, Hummers E, Muller C. Interprofessional collaboration in the home care setting: perspectives of people receiving home care, relatives, nurses, general practitioners, and therapists-results of a qualitative analysis. BMC Prim Care. 2024 Mar 4;25(1):79. doi: 10.1186/s12875-024-02313-8.
PubMed 38438843Tetzlaff B, Scherer M, Balzer K, Steyer L, Kopke S, Friede T, Maurer I, Weber CE, Konig HH, Konnopka A, Ruppel T, Mazur A, Hummers E, Mueller CA. Development of an interprofessional person-centred care concept for persons with care needs living in their own homes (interprof HOME): study protocol for a mixed-methods study. BMJ Open. 2023 Jul 14;13(7):e069597. doi: 10.1136/bmjopen-2022-069597.
PubMed 37451715
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of an Interprofessional, Person-centered Care Concept for People Living at Home With Care Needs.
- ClinicalTrials.gov ID
- NCT05149937
- Acronym / sponsor ID
- interprof HOME / 2020-00425
- Conditions
- Utilization of Nursing, Medical and Therapeutical Care of People Living at Home With Care Needs
- Keywords
- interprofessional collaboration, reduction of hospitalisation, people living at home with care needs
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study stopped before first patient inclusion. Mixed-methods-study (part a) completed per protocol, explorative survey (part b) withdrawn due to organizational reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 8 Dec 2021 (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 aim of the project is to develop and pilot measures to optimize the person-centered cooperation between nursing services, general practitioners and members of the therapeutic professions in the care of people living at home with care needs, so that hospital admissions and the use of unplanned medical and rescue services are avoided, the quality of life is improved and a deterioration in the need for long-term care can be stopped.
This is done by developing an interprofessional person-centered collaboration-concept, perform an explorative mixed-methods-study: interviews, focus groups, expert workshops, survey of best practices, shadowing, questionnaires.
Detailed description
Description of mixed-methods-study:
- Interviews with
- 20 patients,
- 20 relatives,
- 5 experts of health insurance professionals,
- and 3 focus groups à 8 persons with general practioniers, nurses, therapists.
- investigation of best practice cases
- explorative survey of 100 cases in each group:
- general practitioner
- nursing services
- therapists
- persons in need of care
- family members of persons in need of care
The mixed-methods-study is analysed in different ways:
- structured content analysis
- case-based qualitative analysis of interviews
- descriptive analysis
The mixed-methods-study has been approved by the ethics committee and is recruiting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: interprofessional, person-centered care conceptImplementation of interprof Home measures to improve cooperation between nursing services, general practitioners and members of the therapeutic professions in the care of people living at home with care needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- years of age >18
- receipt of benefits in the form of outpatient care according to SGB XI,
- preliminary / final classification of care ≥level 2
- expected life expectancy >6 months
- informed consent
Key exclusion criteria (3 listed)
- Living in nursing home / planned move-in within the following 6 months
- claim acceptance of SAPV
- participation in scientific 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 |
|---|---|---|
| interprofessional, person-centered care conceptinterprofessional, person-centered care concept | Other | Interventional group |
Primary outcome
cumulative number of hospitalisation
Time frame: 40 months
Cumulative incidence of hospitalisations within 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Derived from this study: PubMed 41241758Tetzlaff B, Mazur AL, Sekanina U, Huckle T, Dano R, Hockelmann C, Diel M, Bremer L, Kuhn A, Romanski AM, Kuba S, Ruppel T, Balzer K, Kopke S, Maurer I, Weber CE, Scherer M, Hummers E, Muller CA. Development of an interprofessional person-centred care concept for persons with care needs living in their own homes in Germany (interprof HOME): a mixed methods study. BMC Prim Care. 2025 Nov 15;26(1):363. doi: 10.1186/s12875-025-03098-0.
- Derived from this study: PubMed 38438843Sekanina U, Tetzlaff B, Mazur A, Huckle T, Kuhn A, Dano R, Hockelmann C, Scherer M, Balzer K, Kopke S, Hummers E, Muller C. Interprofessional collaboration in the home care setting: perspectives of people receiving home care, relatives, nurses, general practitioners, and therapists-results of a qualitative analysis. BMC Prim Care. 2024 Mar 4;25(1):79. doi: 10.1186/s12875-024-02313-8.
- Derived from this study: PubMed 37451715Tetzlaff B, Scherer M, Balzer K, Steyer L, Kopke S, Friede T, Maurer I, Weber CE, Konig HH, Konnopka A, Ruppel T, Mazur A, Hummers E, Mueller CA. Development of an interprofessional person-centred care concept for persons with care needs living in their own homes (interprof HOME): study protocol for a mixed-methods study. BMJ Open. 2023 Jul 14;13(7):e069597. doi: 10.1136/bmjopen-2022-069597.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing interprofessional, person-centered care concept in people with Utilization of Nursing, Medical and Therapeutical Care of People Living at Home With Care Needs, run by University Medical Center Goettingen.
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 6 inclusion and 3 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: withdrawn, as of the sponsor's last update on 6 Oct 2023. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
cumulative number of hospitalisation (time frame: 40 months). 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 NCT05149937, which also lists 3 linked publications.
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 6 Oct 2023.