IntelligentCare: Wearable-based Intervention

NCT05777291 | Recruiting DMC

• 1 other identifier: 500
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Physical activity

  Physical activity measured trough International Physical Activity Questionnaire Short Form. The responses to these questions are used to calculate an individual's total physical activity level, expressed in metabolic equivalent of task (MET) minutes per week. The IPAQ-Sf assigns a MET value to each activity reported by the individual and multiplies this value by the reported duration of the activity to calculate the total MET-minutes per week for each domain. The total MET-minutes per week for all domains are then summed to give the total physical activity level for the individual. The results of the IPAQ-Sf can be used to classify individuals into different categories of physical activity levels, such as low, moderate, or high.

  6 months after study entry

Secondary Outcomes (8)

• Physical performance

  6 months after study entry

• Fall risk

  6 months after study entry

• Weight

  6 months after study entry

• Abdominal circunference

  6 months after study entry

• Calf circunference

  6 months after study entry

Study Arms (2)

Experimental arm

EXPERIMENTAL

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)

Device: Activity watch monitoring; Device: Sleep mattress monitoring; Behavioral: Physical activity counseling

Control arm

ACTIVE COMPARATOR

Patients will be given physical activity recommendations only

Behavioral: Physical activity counseling

Interventions

Activity watch monitoring DEVICE

Patients will be using activity devices during the study period

Experimental arm

Sleep mattress monitoring DEVICE

Patients will be using sleep mattress during the study period

Experimental arm

Physical activity counseling BEHAVIORAL

Physical activity counseling in accordance to the Swedish model

Control arm; Experimental arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GLSMED Learning Health S.A.: lead

Study Sites (1)

Hospital da Luz Learning Health

Lisbon, Portugal

RECRUITING

Related Publications (1)

• 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.

  PMID: 38097933 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Bernardo Neves, MD

  Researcher

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernardo Neves, MD

CONTACT

00351217104544; bernardo.neves@hospitaldaluz.pt

Nuno Silva, PhD

CONTACT

nuno.asilva@luzsaude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The masking procedure will involve blinding the outcome assessors to the treatment allocation of the patients. This means that the outcome assessors will be kept unaware of whether the patients are wearing the device or not.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: unblinded randomized trial with blinded outcome assessors

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 21, 2023
• Study Start: April 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)