NCT03548142

Brief Summary

Palliative and hospice care in advanced dementia: experiences of care givers and benefit of a brochure serving as a decision-making aid Aims:

  • which procedures of palliative and hospice care are practically implemented in ambulatory care and in residential geriatric care,
  • which symptoms the persons with dementia suffer from and how those symptoms are (or are not) treated,
  • to what extend caregivers are informed about relevant aspects
  • how caregivers assess care and which problems, needs and requests exist.
  • Piloting phase for the brochure. To test the comprehensibility and the acceptance of the brochure a study is planned. The caregivers are asked for their opinion whether the brochure is helpful. It is recorded if the reading of the brochure gets the caregivers to engage actively in the participative decision making process.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

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

July 11, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

November 13, 2017

Last Update Submit

April 12, 2019

Conditions

Advanced Dementia

Keywords

Palliative Careadvanced dementialife-prolonging treatmentpatient willadvanced care planning

Outcome Measures

Primary Outcomes (1)

  • Patients' Perceived Involvement in Care Scale

    Involvement is expected, when caregiver at study end achieve one point more in the sum score (sum score maximum is eight points)

    two to three months

Secondary Outcomes (1)

  • family caregivers´satisfaction with care

    Assessment A (inclusion/baseline, before reading the brochure) and Assessment B (after reading the brochure, two to three months after Assessment A)

Interventions

provision of relevant informationBEHAVIORAL

caregivers are provided with brochure that informs about end-of-life issues for persons with advanced dementia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Person with dementia + caregiver live in the Munich area
  • Person with dementia lives in a nursing home or at home
  • Person with dementia is in an advanced stage of the disease (moderate to severe dementia)
  • Informed consent of the caregiver and the person with powers of attorney
  • Caregiver is German-speaking and able to read

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Cognitive Disorders

Munich, Bavaria, 81675, Germany

Location

Related Publications (8)

  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PMID: 1202204BACKGROUND

  • Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. doi: 10.1212/wnl.43.11.2412-a. No abstract available.

    PMID: 8232972BACKGROUND

  • MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.

    PMID: 14258950BACKGROUND

  • Lerman CE, Brody DS, Caputo GC, Smith DG, Lazaro CG, Wolfson HG. Patients' Perceived Involvement in Care Scale: relationship to attitudes about illness and medical care. J Gen Intern Med. 1990 Jan-Feb;5(1):29-33. doi: 10.1007/BF02602306.

    PMID: 2299426BACKGROUND

  • Vohra JU, Brazil K, Hanna S, Abelson J. Family Perceptions of End-of-Life Care in long-term care facilities. J Palliat Care. 2004 Winter;20(4):297-302.

    PMID: 15690832BACKGROUND

  • Biola H, Sloane PD, Williams CS, Daaleman TP, Williams SW, Zimmerman S. Physician communication with family caregivers of long-term care residents at the end of life. J Am Geriatr Soc. 2007 Jun;55(6):846-56. doi: 10.1111/j.1532-5415.2007.01179.x.

    PMID: 17537084BACKGROUND

  • Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2.

    PMID: 35802350DERIVED

  • Riedl L, Bertok M, Hartmann J, Fischer J, Rossmeier C, Dinkel A, Ortner M, Diehl-Schmid J. Development and testing of an informative guide about palliative care for family caregivers of people with advanced dementia. BMC Palliat Care. 2020 Mar 12;19(1):30. doi: 10.1186/s12904-020-0533-3.

    PMID: 32164707DERIVED

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, Principle Investigator

Study Record Dates

First Submitted

November 13, 2017

First Posted

June 7, 2018

Study Start

July 11, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)