Recruiting

mHealth Intervention

Sponsor:

AdventHealth University

Code:

NCT05795036

Conditions

Cardiac Rehabilitation

Physical Activity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

mHealth 1

mHealth 2

Study Details

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. 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

Cardiac Rehabilitation

Physical Activity

Study ID

NCT05795036

Start date

Feb 17, 2023

Status verified date

Jul, 2024

Completion date

Dec 17, 2025

Anticipated

Primary completion date

Aug 17, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

46 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

mHealth 1

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

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.

Primary outcome measure

  • Clients' demographic information will be obtained using a paper questionnaire administered at screening phase [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Chia-Wei Fan, MD

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

Leana Goncalves Araujo, PhD

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

Locations

AdventHealth University

Recruiting

Orlando, Florida, United States, 32803

More Information

Sponsor

AdventHealth University

Last update posted

Jul 12, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AdventHealth University on 2024-07-12.