University Hospital Muenster
Münster, 48149, Germany
NCT Number: NCT07491679
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Münster, 48149, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Patient-reported assessment of symptom intensity (pain, dyspnea, fatigue, and psychological distress) using the Minimal Documentation System 2 (MIDOS-2).
Time frame: At baseline and after 3 months or upon clinical change; overall study duration from November 2025 to May 2027.
Self-reported depressive symptoms measured with the Patient Health Questionnaire-8.
Time frame: At baseline and after 3 months or upon clinical change; overall study duration from November 2025 to May 2027.
Self-reported anxiety symptoms assessed using the Generalized Anxiety Disorder Scale-7.
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.
Health-related quality of life assessed using the EuroQol EQ-5D-3L questionnaire that comprises an index score and a visual analogue scale.
Time frame: After 3 months of use or at end of participation; overall study duration from November 2025 to May 2027.
Satisfaction with care and usability of the telemedicine intervention, assessed with the ZUF-8 questionnaire.
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.
Clinician-rated functional status including mobility, self-care, and intake using the Palliative Performance Scale.
Time frame: Baseline and after 3 months or upon clinical change over the whole study duration from November 2025 to May 2027.
Subjective well-being measured using the WHO-5 Well-Being Index.
Time frame: Regularly throughout the observation period during the whole study duration from November 2025 to May 2027.
Clinician-rated physical functioning using the ECOG Performance Status scale.
Time frame: At baseline and upon major clinical change during the whole study duration from November 2025 to May 2027.
Prognosis estimation combining clinical parameters using the Palliative Prognostic Index (PPI).
Time frame: Baseline and weekly during caregiving period during the whole study duration from November 2025 to May 2027.
Caregiver emotional distress measured with the Screen for Anxiety Related Emotional Disorders (SCARED).
Time frame: Baseline and weekly during caregiving period during the whole study duration from November 2025 to May 2027.
Subjective caregiver burden assessed with the 7-item Zarit Burden Interview short form (ZBI-7).
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.
Exploratory non-validated item assessing perceived social support among caregivers.
Time frame: Approximately 2 months after patient death; overall study duration from November 2025 to May 2027.
Satisfaction of family members with care and communication using the FAMCARE-2 short form.
Time frame: After completion of the telemedicine use phase; overall study duration from November 2025 to May 2027.
Perceived usability and acceptance of telehealth among professionals, measured with the Telehealth Usability Questionnaire (TUQ).
Time frame: After completion of the telemedicine use phase; overall study duration from November 2025 to May 2027.
Perceived usability and functionality of the telemedicine platform using the System Usability Scale (SUS).
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.
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.
Time frame: At baseline and after 3 months or at end of participation overall study duration from November 2025 to May 2027.
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.
University Hospital Muenster
Other
Implementation of Telemedicine in Palliative Care in the Outpatient Sector of North Rhine-Westphalia (IMPULS-NRW)
Acronym: IMPULS-NRW
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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