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临床试验/NCT03615027
NCT03615027Unknown不适用

Dementia-specific Intervention of Advance Care Planning

University of Lausanne Hospitals2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年8月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Change in participants' anxiety and depression levels

研究概览

简要总结

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).

详细描述

Study background and aims:

Advance care planning (ACP) is a structured communication process between an individual, his family, and his healthcare agent (if existing), facilitated by a healthcare provider. The aim is to identify the personal values of the individual, reflect on the meanings and consequences of anticipated illness scenarios, define goals and preferences of care for these situations, issue appropriate documents and legal instruments that will help direct future healthcare decisions, and review these steps at adequate intervals. ACP emphasizes communication in anticipation of a future deterioration of a person's health. Even though dementia entails the loss of decision-making capacity, advance care planning is yet to become widespread. This study aims to close the gap and create a dementia-specific ACP intervention that:

  • Support patient autonomy through advance care planning
  • Improve participants' satisfaction and perceived control;
  • Increase planning decisions and surrogate's knowledge of patients' preferences and values.

Procedure and measure:

Pre-intervention assessment (Visit 1):

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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;

排除标准

  • 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.

研究组 & 干预措施

Intervention

Experimental

see detailed description

干预措施: Dementia-specific advance care planning (Behavioral)

结局指标

主要结局

Change in participants' anxiety and depression levels

时间窗: Visit 1 and V4 (=V1 + 4-6 weeks)

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.

Change in participants' decisional conflict level

时间窗: Visit 1 and V4 (=V1 + 4-6 weeks)

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).

Changes in patients' psychological autonomy and perceived control

时间窗: Visit 1 and V4 (=V1 + 4-6 weeks)

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.

Participants' satisfaction with the intervention

时间窗: Visit 1 and V4 (=V1 + 4-6 weeks)

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.

Change in proxies' perception of the burden

时间窗: Visit 1 and V4 (=V1 + 4-6 weeks)

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).

次要结局

未报告次要终点

研究者

发起方
University of Lausanne Hospitals
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesca Bosisio

Research assistant

University of Lausanne Hospitals

研究点 (2)

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