Heart Rate Informed Changes in Care for Non-Communicating Patients

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05738278
• Other study ID #: #2016/1956
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: February 2024
• Source: University of Oslo
• Contact: Bjørnar Hassel, Professor
• Phone: 0047 98829754
• Email: bjornar.hassel[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Intellectual Disability

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo
Norway	University of Oslo	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Serum concentrations of MCP-1, IL-1RA, IL-8, TGFß1, 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, TGFß1, and IL-17) as evaluated at the beginning and the end of the study period.	6 weeks
Secondary	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