None listed
Conditions
Brief summary
The study focuses on applying a new assessment technology to better detect and monitor pain in older people with dementia living in the community. Elderly people, particularly those with dementia frequently suffer from painful conditions that are poorly treated. This may be because dementia makes it difficult for people to remember and tell their doctors how bad their pain was and is, or in some cases when or where pain exists. Although tools exist to assist people in documenting their pain experience these are often not designed to meet the needs of people living with dementia. PainChek® has been designed to assess pain in people with dementia who are unable to verbalise their pain and it has been suggested by people living with dementia that it might be a valuable tool for documenting their pain experience to allow them to better interaction with those caring for their chronic pain. For this reason, this study aims to evaluate the use of the PainChek® app by people with mild dementia as an aide-memoir. It is hoped that the findings of this study will contribute to better pain management among this community-dwelling vulnerable population.
Interventions
PainChek® is an approved medical device in the form of a smart device app, which combines artificial intelligence and smart automation to identify and quantify pain in real time. The app has been validated and used for assessing pain in people with moderate to severe dementia. PainChek® works by using facial recognition technology and analysis to detect pain through facial muscle movements which indicate the presence of pain. The user then enters other observed pain cues (e.g. vocalisation, movements and behaviours) exhibited by the patient via a series of checklists, and the app automatically calculates a pain score and assigns a pain intensity. The app does not store any images of the patient and adheres to strict medical privacy and confidentiality legislation. Over time the app provides the user with a record of the patient’s pain experience including the intensity of their pain and how the pain impacted on how they feel and behaved. In the context of this study, a person living with dementia would use PainChek® to document their pain experience, effectively using the app as an electronic pain diary. He or she could then share this information with the clinician looking after their pain. This study will be conducted in community-dwelling people with mild dementia to allow them to document their own pain for 6 months. The primary researcher will be in contact with the people with mild dementia either by face to face or via teleconference.They will be provided with in-app and online training (accessible from the app), be supported by the primary researcher and the PainChek Ltd (www.painchek.com). They will be instructed regularly document their pain, both weekly and on an as required basis. They will also be contacted weekly by the primary researcher to ascertain if they are comfortable using the app and to address any questions or concerns about its use. . The outcome of these studies includes the Health-ITUES scores (usability feedback). The Health-ITUES consists of 20 items, with the higher scores correlating to higher technology usability. The 20-item scale consists of four subscales: (1) quality of work life, (2) perceived usefulness, (3) perceived ease of use, and (4) user control. The clinical impact of using PainChek® will be examined by evaluating pain severity scores that will already be collected from PainChek®.
Sponsors
Curtin University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria of the participants includes: diagnosed or classified with mild dementia by their general practitioner or specialist, living independently at home, i.e. are able to complete activities of daily living, have a past medical history of pain, are current smart device user and are willing to participate.
Exclusion criteria
People with dementia exclusion criteria: 1) If the people with dementia is clinically unwell, deemed ineligible or if it is inappropriate to include. 2)Those not fluent in English or who have difficulty understanding English
Outcome results
None listed