Heart Rate Informed Changes in Care for Non-Communicating Patients

Not Applicable

Recruiting

• Conditions: Communication, Nonverbal; Autism Spectrum Disorder; Intellectual Disability
• Interventions: Behavioral: Delayed HR-informed specific change in routine; Behavioral: HR-informed change in routine

• Registration Number: NCT05738278
• Lead Sponsor: University of Oslo

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

Study Timeline

• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2023-02-10
• Study First Posted: 2023-02-22
• Study Start: 2023-02-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control group	Delayed HR-informed specific change in routine	After 4 weeks mapping phase, patient-specific HR-informed intervention from week 5.
Intervention group	HR-informed change in routine	After 2 weeks mapping phase, patient-specific HR-informed intervention from week 3.

Primary Outcome Measures

Name	Time	Method
Situations identified by 2 standard deviation increase in HR	11 weeks	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.

Secondary Outcome Measures

Name	Time	Method
HRV (ms)	6 weeks	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.
Serum concentrations of MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17 (pg/ml)	6 weeks	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.
Scores on quality of communication	6 weeks	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.

Trial Locations

Locations (2)

University of Oslo; 🇳🇴 Oslo, Norway

Oslo University Hospital; 🇳🇴 Oslo, Norway