IMPULS-NRW: Telemedicine in Specialized Outpatient Palliative Care

NCT07491679 | Active Not Recruiting

• 1 other identifier: 2025-805-f-S
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End of Life; Palliative Patients; Outpatient Treatment

Keywords

Palliative care; Telemedicine

Outcome Measures

Primary Outcomes (17)

• Symptom Burden (MIDOS-2)

  Patient-reported assessment of symptom intensity (pain, dyspnea, fatigue, and psychological distress) using the Minimal Documentation System 2 (MIDOS-2).

  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.

• Depressive Symptoms (PHQ-8)

  Self-reported depressive symptoms measured with the Patient Health Questionnaire-8.

  At baseline and after 3 months or upon clinical change; overall study duration from November 2025 to May 2027.

• Anxiety Symptoms (GAD-7)

  Self-reported anxiety symptoms assessed using the Generalized Anxiety Disorder Scale-7.

  At baseline and after 3 months or upon clinical change; overall study duration from November 2025 to May 2027.

• Health-Related Quality of Life (EQ-5D-3L)

  Health-related quality of life assessed using the EuroQol EQ-5D-3L questionnaire that comprises an index score and a visual analogue scale.

  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.

• Patient Satisfaction (ZUF-8)

  Satisfaction with care and usability of the telemedicine intervention, assessed with the ZUF-8 questionnaire.

  After 3 months of use or at end of participation; overall study duration from November 2025 to May 2027.

• Functional Status (Palliative Performance Scale, PPS)

  Clinician-rated functional status including mobility, self-care, and intake using the Palliative Performance Scale.

  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.

• Psychological Well-being (WHO-5)

  Subjective well-being measured using the WHO-5 Well-Being Index.

  Baseline and after 3 months or upon clinical change over the whole study duration from November 2025 to May 2027.

• Functional Status (ECOG Performance Status)

  Clinician-rated physical functioning using the ECOG Performance Status scale.

  Regularly throughout the observation period during the whole study duration from November 2025 to May 2027.

• Prognostic Assessment (Palliative Prognostic Index, PPI)

  Prognosis estimation combining clinical parameters using the Palliative Prognostic Index (PPI).

  At baseline and upon major clinical change during the whole study duration from November 2025 to May 2027.

• Caregiver Psychosocial Distress (SCARED)

  Caregiver emotional distress measured with the Screen for Anxiety Related Emotional Disorders (SCARED).

  Baseline and weekly during caregiving period during the whole study duration from November 2025 to May 2027.

• Caregiver Burden (Zarit Burden Interview, ZBI-7)

  Subjective caregiver burden assessed with the 7-item Zarit Burden Interview short form (ZBI-7).

  Baseline and weekly during caregiving period during the whole study duration from November 2025 to May 2027.

• Perceived Social Support (Single-Item Measure)

  Exploratory non-validated item assessing perceived social support among caregivers.

  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.

• Family Satisfaction with Care (FAMCARE-2)

  Satisfaction of family members with care and communication using the FAMCARE-2 short form.

  Approximately 2 months after patient death; overall study duration from November 2025 to May 2027.

• Professional Acceptance and Usability (TUQ)

  Perceived usability and acceptance of telehealth among professionals, measured with the Telehealth Usability Questionnaire (TUQ).

  After completion of the telemedicine use phase; overall study duration from November 2025 to May 2027.

• System Usability (SUS)

  Perceived usability and functionality of the telemedicine platform using the System Usability Scale (SUS).

  After completion of the telemedicine use phase; overall study duration from November 2025 to May 2027.

• Phase of Illness (PCOC)

  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.

  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.

• Spiritual Well-Being (FACIT-Sp-12)

  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.

  At baseline and after 3 months or at end of participation overall study duration from November 2025 to May 2027.

Study Arms (3)

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.

Behavioral: IMPULS-NRW

Caregivers/Relatives

Persons supporting patients in using the app or providing proxy data input with patient consent.

Behavioral: IMPULS-NRW

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.

Behavioral: IMPULS-NRW

Interventions

IMPULS-NRW BEHAVIORAL

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.

Caregivers/Relatives; Healthcare Professionals; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

University Hospital Muenster

Münster, 48149, Germany

Location

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Philipp Lenz, Prof. Dr. med.

  University Hospital Muenster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 19 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: March 24, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2025-12

Locations

DE (1)