Heart Rate Informed Changes in Care for Non-Communicating Patients

Heart Rate Informed Changes in Care for Non-Communicating Patients: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Intellectual Disability; Autism Spectrum Disorder; Communication, Nonverbal
• Intervention / Treatment: Behavioral: HR-informed change in routine; Behavioral: Delayed HR-informed specific change in routine

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bjørnar Hassel, Professor; Phone Number: 0047 98829754; Email: bjornar.hassel@medisin.uio.no
• Study Contact Backup: Name: Emilie SM Kildal; Phone Number: 45481949; Email: eskildal@uio.no

Study Locations

• Norway
  • Oslo, Norway, 0450
    • Recruiting
    • University of Oslo
    • Contact: Bjørnar Hassel, PhD; Phone Number: 004798829754; Email: bjornar.hassel@medisin.uio.no
    • Contact: Emilie SM Kildal; Phone Number: 004745481949; Email: eskildal@uio.no
  • Oslo, Norway, 0192
    • Recruiting
    • Oslo University Hospital
    • Contact: Bjørnar Hassel, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; After 2 weeks mapping phase, patient-specific HR-informed intervention from week 3.	Behavioral: HR-informed change in routine; The intervention is given for a situation occuring at least ten times and accompanied by an increase in HR at least 80% of the time, during the two-week registration period. Change in care (intervention) is introduced from week 3. The intervention is in one of four forms: changes in physiotherapy, e.g., less rigorous movement in the identified painful stretch,; preparations for putting on corrective cast to stabilize joint and/or stretch spastic muscles,; change in procedures for transportation/lifting, e.g., new technique or adaptations made to equipment, or; revised personal hygiene procedure.
Active Comparator: Control group; After 4 weeks mapping phase, patient-specific HR-informed intervention from week 5.	Behavioral: Delayed HR-informed specific change in routine; The intervention is given for a situation occuring at least twenty times and accompanied by an increase in HR at least 80% of the time, during the four-week registration period. Change in care (intervention) is introduced from week 5. The intervention is in one of four forms: changes in physiotherapy, e.g., less rigorous movement in the identified painful stretch,; preparations for putting on corrective cast to stabilize joint and/or stretch spastic muscles,; change in procedures for transportation/lifting, e.g., new technique or adaptations made to equipment, or; revised personal hygiene procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Situations identified by 2 standard deviation increase in HR	The hypothesis is that a 2 standard deviation increase in HR can identify potentially painful care situations that require re-evaluation. Mean HR spike counts will be compared using a one-tailed paired sampled t-test to differentiate between suitable and unsuitable situations for care adjustments.	11 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum concentrations of MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17 (pg/ml)	The hypothesis is that HR-informed changes in a patient-specific care procedures will potentially painful settings and thus reduce pain-related blood biomarkers (MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17) as evaluated at the beginning and the end of the study period.	6 weeks
HRV (ms)	The hypothesis is that HR-informed changes in a patient-specific care procedures will potentially painful settings and thus reduce pain-related biomarkers of HRV as evaluated at the beginning and the end of the study period.	6 weeks
Scores on quality of communication	The hypothesis is that HR as an aid in communication will increase caregivers' understanding of the patient as measured by changes in perceived understanding of the patient from the beginning to the end of the study period.	6 weeks

Collaborators and Investigators

• Sponsor: University of Oslo
• Investigators: Principal Investigator: Bjørnar Hassel, University of Oslo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: February 10, 2023
• First Posted (Actual): February 22, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Biomarkers; Developmental Disabilities; Caregivers; Autistic Disorder; Intellectual Disability; Communication; Heart Rate; Social Interaction
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Intellectual Disability
• Other Study ID Numbers: #2016/1956

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No