跳至主要内容
临床试验/NCT04876911
NCT04876911Unknown不适用

A Single Case Experimental Design Study to Explore the Use of Simulated Presence Therapy as a Formulation Based Intervention for Patients With Dementia Who Are Presenting in Distress.

NHS Greater Glasgow and Clyde2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
13
试验地点
2
主要终点
Frequency Chart

研究概览

简要总结

It is known that persons with a diagnosis of dementia can experience distress associated with the condition. There are different ways that distress is expressed between these persons, but some common occurrences include physical or verbal aggression, tearfulness, upset, confusion and asking repetitive questions. Medications have typically dominated management of symptoms of distress in dementia, and whilst effective, can result in other problems, such as dependency and reduced effectiveness over time. Non-medical interventions may help to reduce distress without the pitfalls of medications. One such intervention is Simulated Presence Therapy.

Simulated Presence Therapy involves playing an audio and/or visual recording with a comforting message from a loved one to a person with dementia to reduce distress. At present, there are few studies examining its effectiveness, with some indication that Simulated Presence Therapy can benefit some people, but this outcome is not consistent. One reason for this may be due to the focus on diagnosis and symptoms in previous studies rather than 'formulation'. Formulation is an approach to healthcare that attempts to arrive at an understanding of a patient's concern(s), taking into account the views of the patient, their loved ones and other healthcare professionals, as well as psychological theory and research evidence.

This study aims to determine if Simulated Presence Therapy delivered via an iPad, when used within a formulation, reduces distress in patients with moderate to severe dementia admitted for long-term care in a care home or inpatient hospital ward. This study will also examine how user-friendly and helpful Simulated Presence Therapy was for healthcare professionals who administer it. Participants may not have the ability to provide consent; therefore, this will be obtained from the legal guardian or next of kin.

All participants will have received a formulation that identifies Simulated Presence Therapy as the preferred intervention. Their occurrence will be counted on a chart and tallied each day before and after the intervention is introduced. The healthcare staff who administer Simulated Presence Therapy will complete a questionnaire to evaluate their opinions on its user-friendliness and effectiveness. It is hoped that this study may enable service providers to better understand how to integrate Simulated Presence Therapy into healthcare services for persons with a diagnosis of dementia.

详细描述

Background: Persons with dementia (PwD) often present with a cluster of signs or symptoms of distorted perceptions, thoughts, mood and behaviours, commonly referred to as the behavioural and psychological symptoms of dementia. Psychosocial conceptualisations posit that these symptoms manifest as a result of distress arising from an unmet need; thus, the term 'stressed and distressed behaviours' (SDB) may more accurately represent the aetiology of these symptoms. This ethos has been aggregated into the Newcastle model, first conceptualised by Dr Ian James and his colleagues, which emphasises a formulation-based approach to dementia care. Formulation refers to the process of collaboratively developing a hypothesis regarding an individual's difficulties by incorporating psychological theory and evidence.

Although formulation-based approaches are become more widespread, prescribing practices for medical treatments remains suboptimal across dementia care settings. Considering the personal, societal and economic burdens of SDB in PwD, coupled with the disadvantages of pharmacological interventions, there remains a real need to develop effective non-pharmacological, psychosocial alternatives. One such intervention is Simulated Presence Therapy (SPT).

SPT is an intervention that involves playing a video and/or audio recording of a loved one to a PwD with a reassuring message when they present with SDB. Studies examining the efficacy of SPT are sparse; however, what little research that has been conducted has highlighted its effectiveness in some instances. Thus far, studies have not explored SPT when it has been identified as a way of addressing an unmet need through a formulation-driven assessment process. Instead, it has been applied to participants within specific care settings with a symptom rather than formulation-based approach. Hence, this study will explore the efficacy of SPT as part of a formulation-driven approach, grounded in the Newcastle model.

Aim/objectives (s): The present study will aim to investigate the efficacy of SPT for SDB in PwD when it has been specifically identified via a Newcastle formulation as the preferred intervention within care homes and hospital wards operated by the National Health Service of Greater Glasgow and Clyde (NHSGGC) and their associated Health and Social Care Partnerships (HSCP). The research is being conducted to fulfil part of the requirements of the Principal Investigator's Doctorate in Clinical Psychology Qualification at the University of Glasgow, and the University will therefore be an additional collaborating organisation. In terms of objectives:

  • Primary Objective - Introduction of SPT will significantly reduce SDB during day-to-day activities when compared to activities without SPT.
  • Secondary Objective - What is the acceptability of SPT amongst healthcare professionals that administer it?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • For participants:
  • A resident within a care home or hospital ward setting operated by NHS Greater Glasgow and Clyde and/or Glasgow City HSCP, Inverclyde HSCP and/or Renfrewshire HSCP.
  • Persons aged ≥ 65 years.
  • First language must be English.
  • A diagnosis of any form of dementia within the moderate to severe stages, defined as a score of at least '19' on the validated Dementia Severity Rating Scale.
  • Present with SDB as confirmed by a Newcastle formulation constructed by a psychologist with multidisciplinary input.
  • Having retained the relevant cognitive faculties required to engage with audio-video technologies, including attention, recognition and communication as confirmed by a Newcastle formulation constructed by a clinical psychologist with multidisciplinary input.
  • For informants, inclusion requires proficiency in the English language and having known the participant before and/or after the participants diagnosis of dementia, as well as having interacted with the participant in any capacity over the previous year.
  • For recorders, inclusion criteria involved proficiency in English language and ongoing contact/interaction with the participant for whom the recording is being made. This would be made clear through consultation with the care team and the Newcastle formulation that will have been made as part of routine practice.
  • Finally, regarding professionals, inclusion involves proficiency in English language and being employed by NHSGGC and having worked directly on a regular basis with the participant at point of recruitment (i.e. once over the previous 3-month period).

排除标准

  • For participants:
  • No relative/friend/caregiver available to be recorded.
  • Significant vision and/or hearing impairments that cannot be corrected.
  • Pre-existing neurological or severe psychiatric disorder (e.g. psychosis, bi-polar disorder).
  • Diagnosed or suspected intellectual and developmental disability.
  • For informants, the main exclusion criteria include being unable to understand English.
  • For the recorders, exclusion criteria involve possible speech deficits or issues that may impact the quality of the recording and/or having a full face covering that prevents a recognition of a person on video. Additionally, if someone does not have a close relationship or has a contentious relationship with the participant, they would not be eligible to be recorded. This would be made clear through consultation with the care team and the Newcastle formulation that will have been made by the team as part of routine practice.
  • Finally, regarding professionals, the main exclusion criteria would be not having been familiarised with the SPT procedure.

结局指标

主要结局

Frequency Chart

时间窗: 21 to 48 days

A frequency chart which is used to tally the occurrence of stressed/distressed behaviours per day by healthcare staff.

次要结局

  • UTAT-informed staff questionnaire(10-15 minuted per participant.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验