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

NCT05795036 | Recruiting

• 1 other identifier: 1848850-2
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiac Rehabilitation; Physical Activity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Hope Clinic

EXPERIMENTAL

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; Device: mHealth 2

Interventions

mHealth 1 DEVICE

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

Hope Clinic

mHealth 2 DEVICE

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

Hope Clinic

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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").

Sponsors & Collaborators

• AdventHealth University: lead

Study Sites (1)

AdventHealth University

Orlando, Florida, 32803, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Chia-Wei Fan, MD

CONTACT

407-609-1388; chia-wei.fan@ahu.edu

Leana Goncalves Araujo, PhD

CONTACT

407-609-1388; leana.goncalvesaraujo@ahu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will be randomly assigned to either the intervention group or the control group
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 3, 2023
• Study Start: February 17, 2023
• Primary Completion: August 17, 2025
• Study Completion: December 17, 2025
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

US (1)