Clinical trial NCT05738278: Heart Rate Informed Changes in Care for Non-Communicating Patients
Official title: Heart Rate Informed Changes in Care for Non-Communicating Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Intellectual Disability
Communication, Nonverbal
Keywords: Heart Rate
Autistic Disorder
Intellectual Disability
Social Interaction
Caregivers
Developmental Disabilities
Communication
Biomarkers
Pain
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 38
Sex: ALL
Minimum age (years): 5
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Thirty-eight non-verbal patients are recruited. HR is taken as a marker of acute pain. HR-Variability (HRV) and pain-related inflammatory cytokines (MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17) are collected as measures of long-term pain. Caregivers will be asked to what degree they observe pain in their patients and how well they believe they understand their patient's expression. Collection is set to primary care institutions. HR is measured 8 hours/day over 2 weeks to identify increase of HR associated with potentially painful situations. Changes in procedures are in the form of change in 1) rigorousness of stretching, 2) preparations for casts, 3) lifting technique, or 4) personal hygiene procedure. To differentiate effects due to procedure-change from effects of covariates such as increased attentiveness when using HR; half the study group will start intervention in week 3 while the delayed group will continue data collection for another 2 weeks before introducing procedure changes.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overarching aim is to generate knowledge to reduce incidence of pain in non-verbal patients' everyday life. The trial will 1) evaluate how HR can be used to identify potentially painful care procedures that should be re-evaluated in terms of the approach taken; 2) test the effect of heart rate (HR)-informed changes in potentially painful care procedures on biomarkers of pain, and 3) assess how six weeks of communication through HR affects the quality of communication between patient and caregiver.

Detailed description: Detailed protocol to be published as journal article with reference to Clinicaltrials.gov-registration. Preprint available: https://osf.io/gan42

Eligibility criteria: Inclusion Criteria:

* Between 5 and 70 years of age at the time of data collection
* Autism spectrum disorder as evaluated by clinical psychologist
* Communication difficulties
* Living at a care home with round-the-clock staff for at least five days a week; or attending one-to-one staffed school/day-care at least five days a week.
* Written informed consent is obtained from the subjects' legal representative.

Exclusion Criteria:

- Having any autoimmune disorder or any type of cancer with ongoing chemotherapy.

Primary outcomes:
measure: Situations identified by 2 standard deviation increase in HR
timeFrame: 11 weeks
Secondary outcomes:
measure: HRV (ms)
timeFrame: 6 weeks
measure: Serum concentrations of MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17 (pg/ml)
timeFrame: 6 weeks
measure: Scores on quality of communication
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
affiliation: University of Oslo
name: Bjørnar Hassel
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kildal E, Stadskleiv K, Boysen ES, Oderud T, Dahl IL, Seeberg TM, Guldal S, Strisland F, Morland C, Hassel B. Increased heart rate functions as a signal of acute distress in non-communicating persons with intellectual disability. Sci Rep. 2021 Mar 19;11(1):6479. doi: 10.1038/s41598-021-86023-6.