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Advanced DementiaNCT03548142

Advanced Dementia and End-of-life

A study testing provision of relevant information in people with Advanced Dementia, run by Technical University of Munich at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Dementia
What is being tested?
provision of relevant information
How many people
38 participants
Where
1 siteGermany
Study dates
11 Jul 2017to 1 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Center for Cognitive Disorders

    Munich, Bavaria, 81675

Other trials in Germany

About this study

Official title: 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:

Read more
  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.
  1. 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.
Read the 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.

Being tested
provision of relevant information
Keywords
Palliative Care, advanced dementia, life-prolonging treatment, patient will, advanced care planning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • provision of relevant informationBehavioural

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: two to three months

Secondary outcomes (1)

  1. family caregivers´satisfaction with care

    the adapted version of End of life in dementia-Satisfaction with Care, (SWC-EOLD)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2018
  2. Study start11 Jul 2017
  3. Primary completion1 Sep 2018
  4. Study completion1 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03548142
Sponsor's protocol ID
palliative study
Status last verified
Apr 2019
First submitted
13 Nov 2017
Last updated
16 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 1202204

  • 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.

    PubMed 8232972

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

    PubMed 14258950

  • 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.

    PubMed 2299426

  • 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.

    PubMed 15690832

  • 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.

    PubMed 17537084

  • 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.

    PubMed 35802350

  • 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.

    PubMed 32164707

Questions about this trial

What is this clinical trial studying?

A study testing provision of relevant information in people with Advanced Dementia, run by Technical University of Munich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients' Perceived Involvement in Care Scale (time frame: two to three months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03548142, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.

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