Heart Rate Informed Changes in Care for Non-Communicating Patients

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

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

Conditions
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Autism Spectrum Disorder, Intellectual Disability, Communication, Nonverbal

Intervention / Treatment
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* Behavioral: HR-informed change in routine
* Behavioral: Delayed HR-informed specific change in routine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>After 2 weeks mapping phase, patient-specific HR-informed intervention from week 3. | Behavioral: HR-informed change in routine<br>* 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.<br>|
| Active Comparator: Control group<br>After 4 weeks mapping phase, patient-specific HR-informed intervention from week 5. | Behavioral: Delayed HR-informed specific change in routine<br>* 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.<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Rate, Autistic Disorder, Intellectual Disability, Social Interaction, Caregivers, Developmental Disabilities, Communication, Biomarkers, Pain