Telehealth Intervention Involving HEARTS Technical Package and Activity Monitor to Promote Physical Activity Post-stroke

Federal University of Minas Gerais

Status: Enrolling

Conditions: Stroke

Treatments: Behavioral: Telehealth intervention: HEARTS technical package + activity monitor (Smartwatch Mi Band 7®); Behavioral: Telehealth intervention: HEARTS technical package

Study type: Interventional

Funder types: Other

Identifiers

NCT06068036

CAAE: 66980723.2.0000.5149

Details and patient eligibility

About

Objectives: The aim of this feasibility randomized controlled trial (RCT) study is to investigate whether the theoretically informed telehealth intervention involving the HEARTS Technical Package and the use of an activity monitor to increase physical activity level post-stroke is feasible and to estimate the parameters for conducting a fully powered RCT.

Design: A Phase 1 feasibility RCT study with blinded assessment will assign eligible participants to experimental or control group. Participants in both groups will undergo a theoretically informed telehealth intervention based on the HEARTS technical package (a face-to-face session and telephone call follow-up). The experimental group will have additional use of the Mi Band 7® Smartwatch activity monitor. For both groups, the intervention will last for 12 weeks. The feasibility outcomes will be identified considering the different phases of conducting the study. A trained researcher, blinded to the group allocation, will collect the sociodemographic, anthropometric, and clinical outcomes, in a university laboratory setting.

Study Outcomes: Feasibility of recruitment, intervention, and measurement, and clinical outcomes.

Conclusions: Results from this feasibility RCT study will inform on the design and sample required for a fully powered RCT with a similar aim.

Full description

Standard Operating Procedures: A non-probabilistic sample will be recruited from the community. Recruitment strategies include: referrals (e.g, phone numbers obtained from other research projects and university extension programs) and advertisements (e.g. physical folders distributed in public places, and electronic pamphlets published on social media). All subjects will be informed about the study procedures and will provide written consent. The feasibility outcomes will be identified considering the different phases of conducting the study. A trained researcher, blinded to the group allocation, will collect the sociodemographic, anthropometric, and clinical outcomes, in a university laboratory setting. Two independent examiners, blinded to the group allocation, will enter the data into a statistical software package, verify any missing or apparently wrong values. Original paper forms will be kept in a secure place. Electronic files will be available only to the research team. Analysis will be carried-out by a researcher, blinded to the group allocation. All individuals will receive an identification code to ensure anonymity.

Statistical analyzes: All analyzes will be performed using SPSS (SPSS Inc., Chicago, IL, USA). Descriptive statistics will be calculated for all outcomes. The effect sizes will be calculated to determine the magnitude of within-groups and between-groups comparisons. The level of significance will be set at 5% and adjusted for multiple comparisons.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of stroke for more than six months;
• ≥18 years of age;
• Be rated as "Inactive" according to Human Activity Profile (HAP);
• Provide medical approval to practice physical activity.

Exclusion criteria

• Positive screening test for possible cognitive alterations;
• Pain or other adverse health condition that compromises the performance of the proposed intervention program, such as vestibular disorders, severe arthritis or any other diagnosis of disease of the nervous system.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Experimental group

Experimental group

Description:

Telehealth intervention involving the HEARTS technical package and the use of Smartwatch Mi Band 7® activity monitor. The HEARTS technical package presents the 5As brief intervention (Ask, Advise, Assess, Assist, Arrange) to promote physical activity participation. Participants will receive a physical activity monitor (as instructed in the HEARTS technical package) and will be monitored by telephone call, once a week, in order to reinforce successes and identify solutions to difficulties (as instructed in the HEARTS technical package) to practice physical activity. These individuals will undertake a 12-week intervention program. In the first week, individuals will perform the first four steps of the 5As brief intervention in person, where they will be instructed on how to use the physical activity monitor, they will receive a diary of regular physical activity practice, will be guided on how to fill it out, and will schedule the best times to receive the weekly telephone call.

Treatment:

Behavioral: Telehealth intervention: HEARTS technical package + activity monitor (Smartwatch Mi Band 7®)

Control group

Active Comparator group

Description:

Participants will undergo the same intervention as the experimental group, but will not receive the physical activity monitor (Smartwatch Mi Band 7®).

Treatment:

Behavioral: Telehealth intervention: HEARTS technical package