IntelligentCare: Wearable-based Intervention

NCT ID: NCT05777291

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2025-03-31

Brief Summary

The benefits of physical activity and adequate sleep are well documented, and their importance strengthens with the increasing prevalence of chronic diseases and multimorbidity. Interventions to promote physical activity and sleep that use commercial activity trackers may be useful non-pharmacological approaches to managing individual health; however, limited evidence exists on their use to improve physical activity in elderly patients with multimorbidity. This study aims to measure the effects of behavioral change techniques (BCTs) delivered by a wearable device on physical activity (PA) and quality of sleep (QS) in elderly patients with multimorbidity. The investigators designed an open-label randomized controlled trial with participants recruited through primary care and a specialist outpatient clinic. Participants must be more than 65 years old, have multimorbidity, and have access to smartphones. All eligible participants will receive PA promotion content and will be randomly assigned to wear a smartwatch. The primary outcome will be the participants' PA measurement at six months using the IPAQ-SF. Secondary outcomes will include changes in the participants' frailty status, biometric measurements, quality of life, and biopsychosocial assessments. A sample size of 40 participants per arm was calculated to detect group differences, with 50 participants recruited and randomized into each arm. This study aims to contribute to a better understanding of PA patterns and the impact of smartwatch-based PA interventions in patients with multimorbidity. The trial's findings are expected to improve our understanding of how physical activity patterns, patient-reported outcomes (PROMs), and healthcare resource utilization are linked in patients with multiple medical conditions. The study will use a registry for locally developed PROMs and data from the participants' medical records to determine how wearable data and medical information data can be used to predict PROMs and unplanned hospital admissions.

Conditions

Multimorbidity; Exercise; Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental arm

Patients will be given physical activity recommendations ABD will be using the study devices: activity watch (Fitbit Sense) and a sleep monitoring mattress (Withings, Sleep Analyzer)

Group Type: EXPERIMENTAL

Activity watch monitoring

Intervention Type: DEVICE

Patients will be using activity devices during the study period

Sleep mattress monitoring

Intervention Type: DEVICE

Patients will be using sleep mattress during the study period

Physical activity counseling

Intervention Type: BEHAVIORAL

Physical activity counseling in accordance to the Swedish model

Control arm

Patients will be given physical activity recommendations only

Group Type: ACTIVE_COMPARATOR

Physical activity counseling

Intervention Type: BEHAVIORAL

Physical activity counseling in accordance to the Swedish model

Interventions

Activity watch monitoring

Patients will be using activity devices during the study period

Intervention Type: DEVICE

Sleep mattress monitoring

Patients will be using sleep mattress during the study period

Intervention Type: DEVICE

Physical activity counseling

Physical activity counseling in accordance to the Swedish model

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Multimorbidity defined as the presence of two or more of the following chronic conditions: hypertension, depression or anxiety, chronic musculoskeletal conditions causing pain or limitation, arthritis and/or rheumatoid arthritis, osteoporosis, asthma, COPD, ischemic heart disease, peripheral artery disease, heart failure, cerebrovascular diseases, chronic stomach or colon conditions, chronic hepatitis, diabetes mellitus, thyroid disorders, any active cancer in the previous five years, chronic kidney disease, chronic urinary conditions, hyperlipidemia, and obesity
• Must have access to their smartphones

Exclusion Criteria

• patients who are sufficiently physically active (IPAQ-SF > 150 min aerobic physical activity per week)
• existing absolute contraindication for PA according to the American College of Sports Medicine (acute myocardial infarction within two days, ongoing unstable angina, uncontrolled cardiac arrhythmia with hemodynamic compromise, active endocarditis, symptomatic severe aortic stenosis, decompensated heart failure, acute pulmonary embolism, pulmonary infarction, deep venous thrombosis, acute myocarditis or pericarditis, acute aortic dissection, physical disability that precludes safe and adequate testing)
• poor comprehension of Portuguese language
• disabling neurological disorder (defined as mRankin score ≥4), severe psychiatric illness, learning disability, dementia and cognitive impairment, registered blind
• housebound or resident in a nursing home or non-ambulant
• advanced cancer
• scheduled for surgery within five months after the first consultation
• orthopedic or rheumatologic diseases with severe impairment
• chronic pain syndromes with inherently reduced mobility

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GLSMED Learning Health S.A.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernardo Neves, MD

Role: PRINCIPAL_INVESTIGATOR

Researcher

Locations

Hospital da Luz Learning Health

Lisbon, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Bernardo Neves, MD

Role: CONTACT

bernardo.neves@hospitaldaluz.pt

00351217104544

Nuno Silva, PhD

Role: CONTACT

nuno.asilva@luzsaude.pt

Facility Contacts

Bernardo Neves, MD

Role: primary

bernardo.neves@hospitaldaluz.pt

References

Neves B, Haghighi ED, Pereira HV, Costa F, Carlos JS, Ferreira D, Moreno P, Ferreira PM, Machado J, Goncalves B, Moreira JM, Leite F, da Silva NA. Impact of a wearable-based physical activity and sleep intervention in multimorbidity patients: protocol for a randomized controlled trial. BMC Geriatr. 2023 Dec 14;23(1):853. doi: 10.1186/s12877-023-04511-y.

Reference Type: DERIVED

PMID: 38097933 (View on PubMed)

Other Identifiers

500

Identifier Type: -

Identifier Source: org_study_id