Heart Rate Informed Changes in Care for Non-Communicating Patients

NCT05738278 | Recruiting

• 1 other identifier: #2016/1956
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Autism Spectrum Disorder; Intellectual Disability; Communication, Nonverbal

Keywords

Heart Rate; Autistic Disorder; Intellectual Disability; Social Interaction; Caregivers; Developmental Disabilities; Communication; Biomarkers; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• HRV (ms)

  6 weeks

• Serum concentrations of MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17 (pg/ml)

  6 weeks

• Scores on quality of communication

  6 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

After 2 weeks mapping phase, patient-specific HR-informed intervention from week 3.

Behavioral: HR-informed change in routine

Control group

ACTIVE COMPARATOR

After 4 weeks mapping phase, patient-specific HR-informed intervention from week 5.

Behavioral: Delayed HR-informed specific change in routine

Interventions

HR-informed change in routine BEHAVIORAL

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: 1. changes in physiotherapy, e.g., less rigorous movement in the identified painful stretch, 2. preparations for putting on corrective cast to stabilize joint and/or stretch spastic muscles, 3. change in procedures for transportation/lifting, e.g., new technique or adaptations made to equipment, or 4. revised personal hygiene procedure.

Intervention group

Delayed HR-informed specific change in routine BEHAVIORAL

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: 1. changes in physiotherapy, e.g., less rigorous movement in the identified painful stretch, 2. preparations for putting on corrective cast to stabilize joint and/or stretch spastic muscles, 3. change in procedures for transportation/lifting, e.g., new technique or adaptations made to equipment, or 4. revised personal hygiene procedure.

Control group

Eligibility Criteria

• Age: 5 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Oslo: lead

Study Sites (2)

Oslo University Hospital

Oslo, 0192, Norway

RECRUITING

University of Oslo

Oslo, 0450, Norway

RECRUITING

Related Publications (2)

• 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.

  PMID: 33742078 BACKGROUND

• Kildal ESM, Quintana DS, Szabo A, Tronstad C, Andreassen O, Naerland T, Hassel B. Heart rate monitoring to detect acute pain in non-verbal patients: a study protocol for a randomized controlled clinical trial. BMC Psychiatry. 2023 Apr 14;23(1):252. doi: 10.1186/s12888-023-04757-1.

  PMID: 37060049 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Intellectual Disability; Nonverbal Communication; Autistic Disorder; Developmental Disabilities; Communication; Pain

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Bjørnar Hassel

  University of Oslo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bjørnar Hassel, Professor

CONTACT

0047 98829754; bjornar.hassel@medisin.uio.no

Emilie SM Kildal

CONTACT

45481949; eskildal@uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the objectives of the study, the identity of test and control treatments will not be known when analysing data. Access to the randomization code will be strictly controlled.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: February 22, 2023
• Study Start: February 27, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)