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

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.

Study Overview

• Status: Recruiting
• Conditions: Physical Activity; Cardiac Rehabilitation
• Intervention / Treatment: Device: mHealth 1; Device: mHealth 2

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chia-Wei Fan, MD; Phone Number: 407-609-1388; Email: chia-wei.fan@ahu.edu
• Study Contact Backup: Name: Leana Goncalves Araujo, PhD; Phone Number: 407-609-1388; Email: leana.goncalvesaraujo@ahu.edu

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32803
      • Recruiting
      • AdventHealth University
      • Contact: Leana Goncalves Araujo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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").

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: mHealth 1; Participants will use Fitbit device to self-monitor their physical activity in 8 weeks.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clients' demographic information will be obtained using a paper questionnaire administered at screening phase	Descriptive statistics will be used to assess completeness of study data, normality of outcome measures, and potential covariates, and to identify potential covariate imbalances between study arms	12 months

Collaborators and Investigators

• Sponsor: AdventHealth University

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2023
• Primary Completion (Estimated): August 17, 2025
• Study Completion (Estimated): December 17, 2025

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1848850-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes