Advanced Dementia and End-of-life

Palliative and Hospice Care in Advanced Dementia: Experiences of Care Givers and Benefit of a Brochure Serving as a Decision-making Aid

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

Aims:

1. Designing a brochure serving as an information tool and decision-making aid used to answer questions concerning palliative and hospice care for care-givers of persons with advanced dementia.

   The brochure shall demonstrate the possibilities and offerings of palliative and hospice care and shall serve to inform about the advanced stages of dementia, the legal basic principles in decision making and ethical problems, treatment options and (palliative) treatment goals.

2. Survey of the palliative, palliative medical and hospice care of persons with advanced dementia in ambulatory settings, as well as in residential geriatric care and the experiences of the care-givers.

   By examining persons with dementia and inspecting the care documents and where applicable the medical files it is to be evaluated:

   • 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.
3. 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.

Study Overview

• Status: Completed
• Conditions: Advanced Dementia
• Intervention / Treatment: Behavioral: provision of relevant information

Detailed Description

Two visits at home or in the residential geriatric care at intervals of eight to twelve weeks are scheduled.

The following data is collected at enrollment:

• Informed consent of the caregiver and of the patient or rather the caregiver with powers of attorney
• Sociodemographic data (caregiver and person with dementia), e.g. age, sex, education, degree of relationship
• Interview of the caregiver using standardized
• Examination of the person with dementia, recording of the treatment and the care situation, cognitive status: Mini-Mental-Status-Test, severity of dementia: Clinical Dementia Rating Scale, performance in basic activities of daily living: Barthel-Index,communication competence, diagnosis, (palliative) medical and hospice care (including specialists in palliative care, specialists in hospice care, general practioners, domiciliary care services, Allgemeine Ambulante Palliativversorgung [AAPV], Spezielle Ambulante Palliativversorgung [SAPV], AAPV and SAPV both being a specific ambulatory palliative care of the statutory health insurance system in Germany, cognitive/neurological/physical symptoms, symptom Management including pharmacological and non-pharmacological treatment, interventions, existence and phrasing of advanced directives and durable power of attorney.

After enrollment the brochure is handed and explained to the caregivers and they are encouraged to read it. It is pointed out that they are contacted after two to three months to answer questions concerning comprehensibility, acceptance, practical consequences and to give a personnel review.

At study end after two to three months standardized interviews are conducted to gather information about comprehensibility and acceptance of the brochure, how it is reviewed by the caregivers and if the reading had direct consequences with regard to knowledge of the caregiver, communicating with nursing staff/physicians, decision making and implementing those decisions.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81675
      • Center for Cognitive Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
family caregivers´satisfaction with care	the adapted version of End of life in dementia-Satisfaction with Care, (SWC-EOLD)	Assessment A (inclusion/baseline, before reading the brochure) and Assessment B (after reading the brochure, two to three months after Assessment A)

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: Bavarian State Ministry of Health and Care; German Alzheimer Society

Publications and helpful links

General Publications

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

Helpful Links

• legal basis for AAPV and SAPV
• Preparation for decision making scale

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2017
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: November 13, 2017
• First Submitted That Met QC Criteria: June 6, 2018
• First Posted (Actual): June 7, 2018

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 12, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Palliative Care; advanced care planning; advanced dementia; life-prolonging treatment; patient will
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: palliative study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No