- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07491679
IMPULS-NRW: Telemedicine in Specialized Outpatient Palliative Care (IMPULS-NRW)
March 18, 2026 updated by: University Hospital Muenster
Implementation of Telemedicine in Palliative Care in the Outpatient Sector of North Rhine-Westphalia (IMPULS-NRW)
This study examines the feasibility, user-friendliness, and impact of digital support in outpatient palliative care.
Patients, relatives, and professional caregivers use the web-based ISPC platform (information system for Palliative Care) and an accompanying app to record symptom progression, vital signs, and care experiences.
In addition, qualitative interviews, focus groups, and usability tests are conducted to analyze experiences, needs, and effects of digital innovations.
The goal is to improve digital support in palliative care in a practical way, optimize patient care, and lay the foundation for sustainable integration into standard care.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Münster, Germany, 48149
- University hospital Muenster
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The study population includes adult patients receiving Specialized Outpatient Palliative Care (SAPV) or Palliative Care Consultation (PKD) from participating tertiary hospitals in Münster, Essen and nearby locations, Germany.
Participants comprise newly admitted patients as well as patients already in care when inclusion is deemed appropriate by the care team.
The population also includes relatives who support or accompany the patient care, as well as professional healthcare providers involved in the patient's palliative care.
All participants must be able to provide written informed consent or have consent proved by a legally authorized representative.
Description
Inclusion Criteria:
- Adults (>18 years) receiving care from participating SAPV/PKD (Specialized Outpatient Palliative Care / Palliative Care Consultation teams)
- Newly admitted patients or those already in care if study participation is deemed appropriate by the care team
- Patients with a direct treatment context to the Central Palliative Care Unit (ZEP) of the University Hospital Muenster
- Ability to provide written informed consent
Exclusion Criteria:
- Minors (<18 years)
- Individuals with language or communication barriers that cannot be reliably compensated by relatives or qualified interpreters
- Impaired consciousness or reduced decision-making capacity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients
Individuals receiving Palliative Care and using the digital IMPULS App for symptom reporting in the form of electronic patient-reported outcomes ePROMs) and optional vital parameters monitoring.
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Participants (patients, relatives, and healthcare providers) will use the ISPC digital platform and its associated mobile application the IMPULS app to support Palliative Care.
Patients can enter ePROMs and vital parameters, access medication plans, and receive relevant care information.
Relatives may provide information on the patient's condition after consent.
Healthcare providers access the web-based ISPC system to review patient data, plan interventions (phone calls, video visits, home visits), and document assessments and care measures.
The intervention aims to improve care coordination, monitoring, and communication through digital support tools.
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Caregivers/Relatives
Persons supporting patients in using the app or providing proxy data input with patient consent.
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Participants (patients, relatives, and healthcare providers) will use the ISPC digital platform and its associated mobile application the IMPULS app to support Palliative Care.
Patients can enter ePROMs and vital parameters, access medication plans, and receive relevant care information.
Relatives may provide information on the patient's condition after consent.
Healthcare providers access the web-based ISPC system to review patient data, plan interventions (phone calls, video visits, home visits), and document assessments and care measures.
The intervention aims to improve care coordination, monitoring, and communication through digital support tools.
|
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Healthcare Professionals
Palliative Care nurses, physicians, and SAPV/PKD teams who review patient-reported data, plan interventions, and document care activities within the ISPC system.
|
Participants (patients, relatives, and healthcare providers) will use the ISPC digital platform and its associated mobile application the IMPULS app to support Palliative Care.
Patients can enter ePROMs and vital parameters, access medication plans, and receive relevant care information.
Relatives may provide information on the patient's condition after consent.
Healthcare providers access the web-based ISPC system to review patient data, plan interventions (phone calls, video visits, home visits), and document assessments and care measures.
The intervention aims to improve care coordination, monitoring, and communication through digital support tools.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Symptom Burden (MIDOS-2)
Time Frame: Baseline (at enrollment) and then weekly until the palliative condition does not allow for the patient to provide this information anymore, until a patient's death or withdrawal from the study; overall study duration from November 2025 to May 2027.
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Patient-reported assessment of symptom intensity (pain, dyspnea, fatigue, and psychological distress) using the Minimal Documentation System 2 (MIDOS-2).
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Baseline (at enrollment) and then weekly until the palliative condition does not allow for the patient to provide this information anymore, until a patient's death or withdrawal from the study; overall study duration from November 2025 to May 2027.
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Depressive Symptoms (PHQ-8)
Time Frame: At baseline and after 3 months or upon clinical change; overall study duration from November 2025 to May 2027.
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Self-reported depressive symptoms measured with the Patient Health Questionnaire-8.
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At baseline and after 3 months or upon clinical change; overall study duration from November 2025 to May 2027.
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Anxiety Symptoms (GAD-7)
Time Frame: At baseline and after 3 months or upon clinical change; overall study duration from November 2025 to May 2027.
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Self-reported anxiety symptoms assessed using the Generalized Anxiety Disorder Scale-7.
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At baseline and after 3 months or upon clinical change; overall study duration from November 2025 to May 2027.
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Health-Related Quality of Life (EQ-5D-3L)
Time Frame: Baseline (at enrollment) and then monthly until the palliative condition does not allow for the patient to provide this information anymore, until a patient's death or withdrawal from the study; overall study duration from November 2025 to May 2027.
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Health-related quality of life assessed using the EuroQol EQ-5D-3L questionnaire that comprises an index score and a visual analogue scale.
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Baseline (at enrollment) and then monthly until the palliative condition does not allow for the patient to provide this information anymore, until a patient's death or withdrawal from the study; overall study duration from November 2025 to May 2027.
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Patient Satisfaction (ZUF-8)
Time Frame: After 3 months of use or at end of participation; overall study duration from November 2025 to May 2027.
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Satisfaction with care and usability of the telemedicine intervention, assessed with the ZUF-8 questionnaire.
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After 3 months of use or at end of participation; overall study duration from November 2025 to May 2027.
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Functional Status (Palliative Performance Scale, PPS)
Time Frame: Weekly until the palliative condition does not allow for the patient to provide this information anymore, until a patient's death or withdrawal from the study; overall study duration from November 2025 to May 2027.
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Clinician-rated functional status including mobility, self-care, and intake using the Palliative Performance Scale.
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Weekly until the palliative condition does not allow for the patient to provide this information anymore, until a patient's death or withdrawal from the study; overall study duration from November 2025 to May 2027.
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Psychological Well-being (WHO-5)
Time Frame: Baseline and after 3 months or upon clinical change over the whole study duration from November 2025 to May 2027.
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Subjective well-being measured using the WHO-5 Well-Being Index.
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Baseline and after 3 months or upon clinical change over the whole study duration from November 2025 to May 2027.
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Functional Status (ECOG Performance Status)
Time Frame: Regularly throughout the observation period during the whole study duration from November 2025 to May 2027.
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Clinician-rated physical functioning using the ECOG Performance Status scale.
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Regularly throughout the observation period during the whole study duration from November 2025 to May 2027.
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Prognostic Assessment (Palliative Prognostic Index, PPI)
Time Frame: At baseline and upon major clinical change during the whole study duration from November 2025 to May 2027.
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Prognosis estimation combining clinical parameters using the Palliative Prognostic Index (PPI).
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At baseline and upon major clinical change during the whole study duration from November 2025 to May 2027.
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Caregiver Psychosocial Distress (SCARED)
Time Frame: Baseline and weekly during caregiving period during the whole study duration from November 2025 to May 2027.
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Caregiver emotional distress measured with the Screen for Anxiety Related Emotional Disorders (SCARED).
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Baseline and weekly during caregiving period during the whole study duration from November 2025 to May 2027.
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Caregiver Burden (Zarit Burden Interview, ZBI-7)
Time Frame: Baseline and weekly during caregiving period during the whole study duration from November 2025 to May 2027.
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Subjective caregiver burden assessed with the 7-item Zarit Burden Interview short form (ZBI-7).
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Baseline and weekly during caregiving period during the whole study duration from November 2025 to May 2027.
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Perceived Social Support (Single-Item Measure)
Time Frame: Once at baseline and, if applicable, during follow-up until the palliative condition does not allow for the patient to provide this information anymore, until a patient's death or withdrawal from the study; overall study duration: Nov 2025 to May 2027.
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Exploratory non-validated item assessing perceived social support among caregivers.
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Once at baseline and, if applicable, during follow-up until the palliative condition does not allow for the patient to provide this information anymore, until a patient's death or withdrawal from the study; overall study duration: Nov 2025 to May 2027.
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Family Satisfaction with Care (FAMCARE-2)
Time Frame: Approximately 2 months after patient death; overall study duration from November 2025 to May 2027.
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Satisfaction of family members with care and communication using the FAMCARE-2 short form.
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Approximately 2 months after patient death; overall study duration from November 2025 to May 2027.
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Professional Acceptance and Usability (TUQ)
Time Frame: After completion of the telemedicine use phase; overall study duration from November 2025 to May 2027.
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Perceived usability and acceptance of telehealth among professionals, measured with the Telehealth Usability Questionnaire (TUQ).
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After completion of the telemedicine use phase; overall study duration from November 2025 to May 2027.
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System Usability (SUS)
Time Frame: After completion of the telemedicine use phase; overall study duration from November 2025 to May 2027.
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Perceived usability and functionality of the telemedicine platform using the System Usability Scale (SUS).
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After completion of the telemedicine use phase; overall study duration from November 2025 to May 2027.
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Phase of Illness (PCOC)
Time Frame: At baseline and at each clinical review or when a change in the patient's clinical condition occurs. This will be proceeded until the patient's death or withdrawal from the study; overall study duration from November 2025 to May 2027.
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Clinical categorization of the patient's current phase of illness according to the Palliative Care Outcomes Collaboration (PCOC) definitions: stable, unstable, deteriorating, terminal, and bereavement.
The phase reflects the clinical status and care needs and is used to monitor transitions across palliative care trajectories.
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At baseline and at each clinical review or when a change in the patient's clinical condition occurs. This will be proceeded until the patient's death or withdrawal from the study; overall study duration from November 2025 to May 2027.
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Spiritual Well-Being (FACIT-Sp-12)
Time Frame: At baseline and after 3 months or at end of participation overall study duration from November 2025 to May 2027.
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Spiritual well-being assessed with the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale (FACIT-Sp-12).
The instrument measures meaning, peace, and faith as components of quality of life in patients with chronic or life-limiting illness.
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At baseline and after 3 months or at end of participation overall study duration from November 2025 to May 2027.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Philipp Lenz, Prof. Dr. med., University hospital Muenster
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
August 1, 2027
Study Registration Dates
First Submitted
January 9, 2026
First Submitted That Met QC Criteria
March 18, 2026
First Posted (Actual)
March 24, 2026
Study Record Updates
Last Update Posted (Actual)
March 24, 2026
Last Update Submitted That Met QC Criteria
March 18, 2026
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-805-f-S
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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