An Exploration of Simulated Presence Therapy as a Formulation Based Intervention for Dementia Related Distress.

NCT04876911 | Unknown

• 2 other identifiers: GN21MH088294075
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Behavioural and Psychiatric Symptoms of Dementia; Stress, Psychological

Keywords

Simulates Presence Therapy; SPT; formulation; electronic device; touchscreen; Intervention; psychosocial; psychological; dementia; dementia care; Newcastle formulation

Outcome Measures

Primary Outcomes (1)

• Frequency Chart

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

  21 to 48 days

Secondary Outcomes (1)

• UTAT-informed staff questionnaire

  10-15 minuted per participant.

Study Arms (2)

Control/Usual Care

NO INTERVENTION

No intervention delivered and care is provided as usual.

Simulated Presence Therapy (SPT)

EXPERIMENTAL

Participants begin to receive the SPT.

Behavioral: Simulated Presence Therapy

Interventions

Simulated Presence Therapy BEHAVIORAL

A video recording of a loved one is played (via an iPad) prior to or during periods where a participant is presenting with stressed/distressed behaviours.

Also known as: SPT, Simulated Presence Intervention

Simulated Presence Therapy (SPT)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

NHSGGC

Glasgow, G12 OXH, United Kingdom

Location

Related Publications (7)

• Abraha I, Rimland JM, Lozano-Montoya I, Dell'Aquila G, Velez-Diaz-Pallares M, Trotta FM, Cruz-Jentoft AJ, Cherubini A. Simulated presence therapy for dementia. Cochrane Database Syst Rev. 2017 Apr 18;4(4):CD011882. doi: 10.1002/14651858.CD011882.pub2.

  PMID: 28418586 BACKGROUND

• Carver, C. S. (1997). Adult attachment and personality: Converging evidence and a new measure. Personality and Social Psychology Bulletin, 23(8), 865-883. https://doi.org/10.1177/0146167297238007

  BACKGROUND

• Clark CM, Ewbank DC. Performance of the dementia severity rating scale: a caregiver questionnaire for rating severity in Alzheimer disease. Alzheimer Dis Assoc Disord. 1996 Spring;10(1):31-9.

  PMID: 8919494 BACKGROUND

• Hazan C, Shaver P. Romantic love conceptualized as an attachment process. J Pers Soc Psychol. 1987 Mar;52(3):511-24. doi: 10.1037//0022-3514.52.3.511.

  PMID: 3572722 BACKGROUND

• James, I. A. (2011). Understanding behaviours in dementia that challenge. Jessica Kingsley Publishers.

  BACKGROUND

• Tible OP, Riese F, Savaskan E, von Gunten A. Best practice in the management of behavioural and psychological symptoms of dementia. Ther Adv Neurol Disord. 2017 Aug;10(8):297-309. doi: 10.1177/1756285617712979. Epub 2017 Jun 19.

  PMID: 28781611 BACKGROUND

• Venkatesh, V., Morris, M. G., Davis, G. B., & Davis, F. D. (2003). User acceptance of information technology: Toward a unified view. MIS Quarterly: Management Information Systems, 27(3), 425-478. https://doi.org/10.2307/30036540

  BACKGROUND

MeSH Terms

Conditions

Stress, Psychological; Dementia

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Danyal A Ansari, BA, MSc

  NHSGGC and University of Glasgow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danyal Ansari A Ansari, BA, MSc

CONTACT

7949 251492; 2509917@student.gla.ac.uk

Jonathan Evans, PhD, DClinP

CONTACT

141 211 0694; jonathan.evans@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multiple Baseline Single Case Experimental Design (SCED) of two phases.

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 7, 2021
• Study Start: June 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: January 31, 2022
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)