Using a mHealth Intervention to Promote Physical Activity in Phase III Cardiac Rehabilitation Clients

NCT ID: NCT05795036

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-17

Study Completion Date

2025-12-17

Brief Summary

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In this study, the investigators will implement a pilot project of using activity tracker (i.e., Fitbit) with phase III CR clients. The study will record the participants' daily steps and sleep patterns for 8 consecutive weeks in natural settings. Two specific aims are identified for this project:

1. Develop an intervention protocol using mHealth to promote Phase III CR clients' self-monitoring of PA.
2. Examine the efficacy of the intervention on clients' PA, sleep patterns, functional capacity and QoL.

Detailed Description

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In this study, the investigators will implement a pilot project of using activity tracker (i.e., Fitbit) with phase III CR clients. The study will record the clients' daily steps and sleep patterns for 8 consecutive weeks in natural settings. Two specific aims are identified for this project:

1. Develop an intervention protocol using mHealth to promote Phase III CR clients' self-monitoring of PA.
2. Examine the efficacy of the intervention on clients' PA, sleep patterns, functional capacity and QoL.

Conditions

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Cardiac Rehabilitation Physical Activity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Participants will be randomly assigned to either the intervention group or the control group

Study Groups

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Hope Clinic

Participants will be recruited from clients admitted to the Phase III CR program at Hope Clinic. An information sheet introducing this study will be provided to clients by the assigned therapist at the Hope clinic after admission.

Group Type EXPERIMENTAL

mHealth 1

Intervention Type DEVICE

Participants will use Fitbit device to self-monitor their physical activity in 8 weeks.

mHealth 2

Intervention Type DEVICE

Participants will use Fitbit device to self-monitor their physical activity in 8 weeks. In addition, they will receive daily motivational text message.

Interventions

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mHealth 1

Participants will use Fitbit device to self-monitor their physical activity in 8 weeks.

Intervention Type DEVICE

mHealth 2

Participants will use Fitbit device to self-monitor their physical activity in 8 weeks. In addition, they will receive daily motivational text message.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* currently receiving Phase III CR at Hope Clinic
* are 18 years of age or older
* can read and communicate in English
* able to follow instructions to walk
* provided signed informed consent
* willing to wear Fitbit throughout the study
* owns a smartphone with text messaging capability (participants need to decide ahead of time if they have a phone plan that is compatible with taking additional text messages without undue financial burden for themselves)
* willing to receive text messages and phone calls from the research team.

Exclusion Criteria

* are pregnant or lactating
* have scheduled surgery or traveling within the next 8 weeks
* currently participating in other health promotion program
* sufficiently or overly active, as determined by a physical activity monitor worn for one week, indicating averaging ≥ 7,500 steps per day ("somewhat overly active").
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AdventHealth University

OTHER

Sponsor Role lead

Responsible Party

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Chia-Wei Fan

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AdventHealth University

Orlando, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Chia-Wei Fan, MD

Role: CONTACT

407-609-1388

Leana Goncalves Araujo, PhD

Role: CONTACT

407-609-1388

Facility Contacts

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Leana Goncalves Araujo

Role: primary

Other Identifiers

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1848850-2

Identifier Type: -

Identifier Source: org_study_id

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