NCT05082389

Brief Summary

Specialised outpatient palliative care (German: Spezialisierte ambulante Palliativversorgung, abbreviation: SAPV) aims to support incurably ill or dying people spending their last lifetime at home. Furthermore, a major goal is to prevent unnecessary hospital admissions. However, they occasionally occur for various reasons. This project aims to explore predictors of readmission in terms of structural factors as well as family caregivers' psychological distress. Study Aims

  1. 1.Identification of structural predictors and caregiver reported predictors for hospital readmissions.
  2. 2.Identification of psychological liabilities of nursing relatives.
  3. 3.Developing a concept to support nursing relatives.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2021

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

1.2 years

First QC Date

May 4, 2021

Last Update Submit

August 10, 2022

Conditions

Keywords

Patient reported outcome (PRO)family caregiversspecialized palliative home-based care

Outcome Measures

Primary Outcomes (1)

  • Circumstances of Unplanned hospital admission

    Hospital admission not intended and/or planned by either professional nor non-professional care givers

    18 months

Secondary Outcomes (6)

  • Quality of Life of primary non-professional care-giver

    18 months

  • Psychological Distress of primary non-professional care-giver

    18 months

  • Anxiety of primary non-professional care-giver

    18 months

  • Depressivity of primary non-professional care-giver

    18 months

  • Characteristics of the non-professional care-giver

    18 months

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients treated in SAPV University hospital Dresden will be investigated by descriptive statistics. All respective non-professional-caregivers will be asked to take part in the survey. They must meet the aforementioned inclusion criteria and provide informed consent.

You may qualify if:

  • adult patients (\>17years)
  • with advanced, non-curable disease with limited life expectancy and complex symptoms
  • treated by a Specialised Home Palliative Care - team
  • providing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Carl Gustav Carus

Dresden, Saxony, 01307, Germany

Location

Related Publications (13)

  • Ullrich A, Ascherfeld L, Marx G, Bokemeyer C, Bergelt C, Oechsle K. Quality of life, psychological burden, needs, and satisfaction during specialized inpatient palliative care in family caregivers of advanced cancer patients. BMC Palliat Care. 2017 May 10;16(1):31. doi: 10.1186/s12904-017-0206-z.

    PMID: 28486962BACKGROUND
  • Gotze H, Brahler E, Gansera L, Schnabel A, Gottschalk-Fleischer A, Kohler N. Anxiety, depression and quality of life in family caregivers of palliative cancer patients during home care and after the patient's death. Eur J Cancer Care (Engl). 2018 Mar;27(2):e12606. doi: 10.1111/ecc.12606. Epub 2016 Nov 17.

    PMID: 27859889BACKGROUND
  • Halkett GKB, Lobb EA, Shaw T, Sinclair MM, Miller L, Hovey E, Nowak AK. Do carer's levels of unmet needs change over time when caring for patients diagnosed with high-grade glioma and how are these needs correlated with distress? Support Care Cancer. 2018 Jan;26(1):275-286. doi: 10.1007/s00520-017-3846-x. Epub 2017 Aug 14.

    PMID: 28808797BACKGROUND
  • Hwang IC, Kim YS, Lee YJ, Choi YS, Hwang SW, Kim HM, Koh SJ. Factors Associated With Caregivers' Resilience in a Terminal Cancer Care Setting. Am J Hosp Palliat Care. 2018 Apr;35(4):677-683. doi: 10.1177/1049909117741110. Epub 2017 Nov 15.

    PMID: 29141459BACKGROUND
  • Spatuzzi R, Giulietti MV, Ricciuti M, Merico F, Fabbietti P, Raucci L, Bilancia D, Cormio C, Vespa A. Exploring the associations between spiritual well-being, burden, and quality of life in family caregivers of cancer patients. Palliat Support Care. 2019 Jun;17(3):294-299. doi: 10.1017/S1478951518000160. Epub 2018 May 11.

    PMID: 29749317BACKGROUND
  • Kobayakawa M, Ogawa A, Konno M, Kurata A, Hamano J, Morita T, Kizawa Y, Tsuneto S, Shima Y, Aoyama M, Miyashita M. Psychological and psychiatric symptoms of terminally ill patients with cancer and their family caregivers in the home-care setting: A nation-wide survey from the perspective of bereaved family members in Japan. J Psychosom Res. 2017 Dec;103:127-132. doi: 10.1016/j.jpsychores.2017.10.012. Epub 2017 Oct 23.

    PMID: 29167039BACKGROUND
  • Roen I, Stifoss-Hanssen H, Grande G, Brenne AT, Kaasa S, Sand K, Knudsen AK. Resilience for family carers of advanced cancer patients-how can health care providers contribute? A qualitative interview study with carers. Palliat Med. 2018 Sep;32(8):1410-1418. doi: 10.1177/0269216318777656. Epub 2018 Jun 1.

    PMID: 29852808BACKGROUND
  • Mehnert A, Lehmann C, Cao P, Koch U. [Assessment of psychosocial distress and resources in oncology--a literature review about screening measures and current developments]. Psychother Psychosom Med Psychol. 2006 Dec;56(12):462-79. doi: 10.1055/s-2006-951828. German.

    PMID: 17160791BACKGROUND
  • Zwahlen D, Hagenbuch N, Carley MI, Recklitis CJ, Buchi S. Screening cancer patients' families with the distress thermometer (DT): a validation study. Psychooncology. 2008 Oct;17(10):959-66. doi: 10.1002/pon.1320.

    PMID: 18203146BACKGROUND
  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PMID: 16717171BACKGROUND
  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PMID: 11556941BACKGROUND
  • Downar J, Goldman R, Pinto R, Englesakis M, Adhikari NK. The "surprise question" for predicting death in seriously ill patients: a systematic review and meta-analysis. CMAJ. 2017 Apr 3;189(13):E484-E493. doi: 10.1503/cmaj.160775.

    PMID: 28385893BACKGROUND
  • Hentschel L, Wellesen A, Krause LC, von Havranek M, Kramer M, Hornemann B, Bornhauser M, Schuler U, Schutte K. Predicting unplanned hospital readmission in palliative outpatients (PRePP) - study protocol of a longitudinal, prospective study to identify informal caregiver-related and structural predictors. BMC Palliat Care. 2022 May 2;21(1):62. doi: 10.1186/s12904-022-00955-y.

Study Officials

  • Katharina Schütte, MD

    University Hospital Dresden; Palliative Care Unit

    PRINCIPAL INVESTIGATOR
  • Leopold Hentschel, Dipl.-Psych.

    University Hospital Dresden; Department of Psychooncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2021

First Posted

October 19, 2021

Study Start

April 12, 2021

Primary Completion

June 30, 2022

Study Completion

July 30, 2022

Last Updated

August 11, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations