OPTImizing CArdiac REhabilitation by REfining Sleep and STress
NCT Number: NCT06505109
Acronym: OPTICARE-RESST
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiovascular Diseases|Cardiac Rehabilitation
Interventions: BEHAVIORAL: RESST
Sponsor: Erasmus Medical Center
Collaborators: Capri Hartrevalidatie|Maxima Medical Center|ZonMw: The Netherlands Organisation for Health Research and Development
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-28
Completion Date: 2027-01
Locations: Máxima Medisch Centrum, Eindhoven, North Brabant, 5631BM, Netherlands|Capri Hartrevalidatie, Rotterdam, South Holland, 3062MA, Netherlands|Capri Hartrevalidatie, The Hague, South Holland, 2597AX, Netherlands

Summary:
The primary objective of this project is to investigate the effectiveness and costs of integrating a behavioural program targeting sleep and stress (the RESST intervention) into cardiac rehabilitation (CR). In addition, the investigators will also study whether parameters regarding diversity (e.g., sex, ethnicity, socioeconomic position) are associated with intervention effectiveness. Furthermore, the investigators aim to explore the (bidirectional) relation between sleep and stress on the one hand, and other lifestyle components and health outcomes on the other hand.

Primary Outcome Measures: Objectively assessed sleep duration, This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously., At baseline, after 3 months, and after 6 months.|Objectively assessed sleep-onset latency, This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously., At baseline, after 3 months, and after 6 months.|Objectively assessed wake after sleep onset, This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously., At baseline, after 3 months, and after 6 months.|Objectively assessed sleep efficiency, This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously., At baseline, after 3 months, and after 6 months.|Self-reported sleep quality, This will be measured with the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Score between 0-21, higher score indicates worse sleep quality., At baseline, after 3 months, and after 6 months.|Perceived stress level, This will be measured with the Perceived Stress Scale-10 (PSS-10) questionnaire. Score between 0-40, higher score indicates higher perceived stress., At baseline, after 3 months, and after 6 months.
Secondary Outcome Measures: Cortisol level, This will be measured by taking a hair sample. The amount of cortisol in the hair will be determined in a lab., At baseline, after 3 months, and after 6 months.|Cortisone level, This will be measured by taking a hair sample. The amount of cortisone in the hair will be determined in a lab., At baseline, after 3 months, and after 6 months.|Weight, Weight will be measured with a digital scale in kilograms., At baseline, after 3 months, and after 6 months.|Height, Height will be measured with a stadiometer in centimeters., At baseline.|Body Mass Index (BMI), Weight and height will be combined to report BMI in kg/m\^2., At baseline, after 3 months, and after 6 months.|Blood pressure, Blood pressure will be measured with a blood pressure monitor., At baseline, after 3 months, and after 6 months.|Smoking behaviour, This will be measured with a carbon monoxide breath tester., At baseline, after 3 months, and after 6 months.|Smoking behaviour, This will be measured with a self-designed questionnaire. The outcome of this questionnaire indicates whether a person smokes/has smoked in the past/does not smoke, what sort of tobacco is being smoked and how much the participant smokes., At baseline, after 3 months, and after 6 months.|Muscle strength, Handgrip strength will be measured with a hand dynamometer., At baseline, after 3 months, and after 6 months.|Physical activity, This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously., At baseline, after 3 months, and after 6 months.|Sedentary behaviour, This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously., At baseline, after 3 months, and after 6 months.|Alcohol use, This will be measured with the five-shot questionnaire. Score between 0-7, higher score indicates higher chance of alcohol overuse, misuse, and dependency., At baseline, after 3 months, and after 6 months.|Health related quality of life, This will be measured with the MacNew questionnaire. Score between 1-7, higher score indicates higher health related quality of life., At baseline, after 3 months, and after 6 months.|Health related quality of life, This will be measured with the EuroQol 5D/EQ5D questionnaire. Score between -0.446 - 1, higher score indicates a better health state. One subscale has a score between 0-100, higher score indicates better perceived health., At baseline, after 3 months, and after 6 months.|Fatigue, This will be measured with the Fatigue Severity Scale (FSS) questionnaire. Score between 9-63, higher score indicates a greater fatigue severity., At baseline, after 3 months, and after 6 months.|Daytime sleepiness, This will be measured with the Epworth Sleepiness Scale (ESS) questionnaire. Score between 0-24, higher score indicates a higher level of daytime sleepiness., At baseline, after 3 months, and after 6 months.|Anxiety and depression, This will be measured with the Hospital Anxiety and Depression Scale (HADS) questionnaire. Score between 0-21 per subscale, higher score indicates severe symptoms of anxiety and depression., At baseline, after 3 months, and after 6 months.|Participation in society, This will be measured with the USER-Participatie (USER-P) questionnare. Score between 0-100, higher score indicates higher participation in society., At baseline, after 3 months, and after 6 months.|Estimated Cardiorespiratory fitness, This will be measured with the FitMáx©-Questionnaire. The outcome of this questionnaire is the estimated maximum oxygen uptake expressed in mL/kg/min. Higher score indicates better cardiorespiratory fitness., At baseline, after 3 months, and after 6 months.|Presence of restless leg syndrome, This will be measured with the RLS rating scale questionnaire. Score between 0-28, higher score indicates more severe symptoms of restless leg syndrome., At baseline.|Presence of insomnia, This will be measured with the Insomnia Severity Index (ISI) questionnaire. Score between 0-28, higher score indicates more severe insomnia complaints., At baseline.|The risk of the presence of obstructive sleep apnoea, This will be measured with the STOP-bang questionnaire. Score between 0-8, higher score indicates higher risk of obstructive sleep apnoea., At baseline.|Costs incurred by the patients, This will be measured with the IMTA Medical Consumption Questionnaire (IMCQ) which aims to determine costs within the health care system., After 3 months and after 6 months.|Productivity costs, This will be measured with the IMTA Productivity Costs Questionnaire (IPCQ) which aims to determine the cost of productivity losses., After 3 months and after 6 months.|Perceived sleep, This will be measured with the Sleep Consensus Diary for 7 days. The Sleep Consensus Diary consists of questions about the experience of sleep, what time the participant went to sleep, and how often the participant woke up., At baseline, after 3 months, and after 6 months.|Diet, This will be measured with an electronic diary. Intake of caffeine and alcohol and timing of the main meal will be measured., At baseline and after 3 months.|Momentary fatigue, This will be measured with an electronic diary., At baseline, after 3 months, and after 6 months.|Momentary stress, This will be measured with an electronic diary., At baseline, after 3 months, and after 6 months.|Adherence to the CR treatment and RESST intervention, This will be measured by recording the number of rehabilitation components attended, such as courses on nutrition or personal counseling., After 3 months.|Treatment Satisfaction, This will be measured with a self-designed questionnaire and consists of questions about the applicability, clarity and logistics of the intervention., After 3 months.|Sex, Female / male / other, At baseline.|Age, Age in years., At baseline.|Cardiac diagnosis, Cardiac diagnosis as defined by ICD-10 that has resulted in referral to cardiac rehabilitation., At baseline.|Educational level, Single-item question (high, middle, or low educated)., At baseline.|Relational status, Single-item question., At baseline.|Cardiac risk factors, Presence of cardiac risk factors (family history, diabetes mellitus, hypertension, dyslipidemia, smoking prior to event)., At baseline.|Cardiac history, History of cardiovascular events and diseases., At baseline.|Medication usage, Number of participants using a certain type of prescribed and/or over-the-counter medication., At baseline, after 3 months, and after 6 months.|Comorbidity, Presence of other diseases., At baseline.|Socioeconomic status, Socioeconomic status indicated by postal code., At baseline.|Origin, Determined by birth country and parents' birth country., At baseline.|Employment, Determined by employment status, and type of job., At baseline.|Drug use, Drug use (yes/no) and drug classification., At baseline.|Current/previous sleep disorder treatment, Description of current and previous treatment for sleeping disorders., At baseline.