Dementia-specific Intervention of Advance Care Planning

NCT03615027 | Unknown

• 1 other identifier: 2018-00785
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study that aims to create a dementia-specific intervention of advance care planning (ACP) and test its feasibility and acceptance with min 20 max 30 patient-relative dyads. The intervention is adapted from the Multiprofessional advance care planning and shared decision-making for end of life care (MAPS) Trials 1 and 2 made at the Zurich University Hospital. The study design is longitudinal (historic): all the dyads will be asked to go through the process (4 visits, see 9.3 Procedures at each visit).

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (5)

• Change in participants' anxiety and depression levels

  Changes in participants' anxiety and depression levels measured with the Hospital Anxiety and Depression scale before (V1) and after (V4) the intervention. The Hospital Anxiety and Depression Scale (HADS) allow the participant to assess her/his mood according to 24 items. Individual's anxiety and depression levels are calculated by summing the score obtained at the eponym subscales, 0 being no anxiety or depression and 21 high anxiety or depression.

  Visit 1 and V4 (=V1 + 4-6 weeks)

• Change in participants' decisional conflict level

  Changes in participants' decisional conflict levels measured with the Decisional conflict scale before (V1) and after (V4) the intervention. The decisional conflict scale allow to participant to assess her/his ambivalence towards a specific treatment decision by choosing on a Lickert scale whether s/he strongly agrees (0 points), agrees (1 point), neither agrees nor disagrees (2 points), disagrees (3 points), or strongly disagrees (4 points) with a list of sentences. Scores are then summed, divided by 16 and multiplied by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).

  Visit 1 and V4 (=V1 + 4-6 weeks)

• Change in proxies' perception of the burden

  Changes in relative's perceptions of the burden measured with the Zarit Burden Inventory before (V1) and after (V4) the intervention. The Zarit Burden Inventory assesses relative's perceived burden of taking care of a sick and/or dependent loved one. Relatives have to answer to indicate if they experienced 22 different situations or feelings never (1 point), rarely (2 points), sometimes (3 points), quite frequently (4 points), or nearly always (5 points). Points at each item are summed: scores range from 22 (low perceived burden) to 110 (high perceived burden).

  Visit 1 and V4 (=V1 + 4-6 weeks)

• Changes in patients' psychological autonomy and perceived control

  Changes in perceptions of patient's personal autonomy measured with the Psychological Autonomy Inventory before (V1) and after (V4) the intervention. The Psychological Autonomy Inventory allows the patient to indicate on a scale from 1 to 5 (1 being never and 5 all the time) how s/he feels autonomous in different aspects of life. Scores at the subscale of decisional control (items 3, 7, 10, 12, 14, 15, 16, 18, 19, 20, 25, 26, 27, and 28) are summed. Items at the subscale of behavioral control (items 1, 2, 4, 5, 6, 8, 9, 11, 13, 17, 21, 22, 23, and 24) are summed. A score of 14 means low decisional or behavioral control, a score of 70 means high decisional or behavioral control.

  Visit 1 and V4 (=V1 + 4-6 weeks)

• Participants' satisfaction with the intervention

  Semi-structured interview at V4 explores dyad's experience with the intervention, whether advance decisions were documented during or after the intervention and how, and comments and suggestions to improve the intervention.

  Visit 1 and V4 (=V1 + 4-6 weeks)

Study Arms (1)

Intervention

EXPERIMENTAL

see detailed description

Behavioral: Dementia-specific advance care planning

Interventions

Dementia-specific advance care planning BEHAVIORAL

see detailed description

Intervention

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients older than 65 years
• Having been diagnosed with an early-stage dementia of Alzheimer's disease aetiology or mixed Alzheimer-vascular aetiology (Montreal cognitive assessement (MoCA) \> 20 and Clinical dementia rating (CDR) \< 1.5);
• Having been informed about the diagnosis by their treating physician and that are regularly followed by him/her;
• Patient that show interest in advance care planning or advance directives;
• Patients with psychiatric disorders can be included if their psychiatric symptoms are controlled and under the supervision of their psychiatrist at the Unit of psychogeriatric care;
• Retaining full decision-making capacity according to the MoCA \> 20 or the clinical judgement a physician or psychologist. During the study, the PI and the facilitators will monitor patient's decision-making capacity clinically;
• Having the necessary French language competencies to engage in conversations;
• Having a close family caregiver over 18 years old, who is informed about the patient's diagnosis, possesses the before mentioned cognitive and communication skills, and is willingly to participate to this pilot intervention;
• Informed Consent for both members of the dyad as documented by signature;

You may not qualify if:

• Patients that have a dementia associated with fronto-temporal lobe degeneration;
• Patients that have mild cognitive impairments (MCI);
• Patients that have moderate to severe cognitive disorders, anosognosia or else, assessed clinically or through scales or based on in-person screening, that suggest decision-making capacity may be impaired;
• The patient or her/his caregiver decide to withdraw from the study;
• Enrolment of the investigator, his/her family members, employees and other dependent persons.
• Patients that have a dementia associated with fronto-temporal lobe degeneration;
• Patients that have MCI;
• Patients that have moderate to severe cognitive disorders, anosognosia or else, assessed clinically or through scales or based on in-person screening, that suggest decision-making capacity may be impaired;
• The patient or her/his caregiver decide to withdraw from the study;
• Enrolment of the investigator, his/her family members, employees and other dependent persons.

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (1)

• Bosisio F, Sterie AC, Rubli Truchard E, Jox RJ. Implementing advance care planning in early dementia care: results and insights from a pilot interventional trial. BMC Geriatr. 2021 Oct 19;21(1):573. doi: 10.1186/s12877-021-02529-8.

  PMID: 34666711 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Francesca Bosisio, PhD

CONTACT

213141053; francesca.bosisio@chuv.ch

Ralf J Jox, MD, PhD

CONTACT

213145434; ralf.jox@chuv.ch

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: Research assistant

Model Details: This clinical trial has a sigle arm: all the dyads will go through the four visits.

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: August 3, 2018
• Study Start: August 3, 2018
• Primary Completion: September 30, 2019
• Study Completion: December 31, 2019
• Last Updated: August 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)