A Study to Promote Physical Activity Motivation in Cardiovascular Disease Patients

NCT05867511 | Completed DMC

• 1 other identifier: 2021-02500
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the feasibility of an app based intervention, which uses questionnaires and personalized motivational messages to achieve change in physical activity and sedentary behaviour of cardiovascular patients. The questionnaires and messages are based on behaviour change theories, such as the transtheoretical model. The intervention will take place over eight weeks. One week before and during the last week, physical activity will be measured via accelerometers. A comprehensive questionnaire will be given before and at the end of the intervention and Feasibility measures will be evaluated at the end as well, including an optional qualitative interview with the participants.

Conditions

Cardiovascular Diseases

Keywords

Cardiovascular Diseases; Health behavior change; Physical activity; Sedentary behavior; App based intervention; Transtheoretical model; Habit formation

Outcome Measures

Primary Outcomes (3)

• Percentage of approached patients included

  The goal is to include at least 10% of approached patients.

  Approx. 5 Months

• Dropout rate

  The goal is that the dropout rate is lower than 50%

  Participants can dropout at any time during the study (during 9 weeks for each participant)

• Completion of study assessments

  The goal is that, on average participants complete at least 4 out of 9 of the questionnaires of the study. Excluding dropouts.

  Participants may fill out study questionnaires weekly during the 8-week intervention or not.

Secondary Outcomes (17)

• Overall satisfaction

  Last questionnaire of the study for each participant (post questionnaire right after the 8 intervention weeks; 9 weeks after study start)

• Usability

  Last questionnaire of the study for each participant (post questionnaire right after the 8 intervention weeks; 9 weeks after study start)

• Engagement

  Last questionnaire of the study for each participant (post questionnaire right after the 8 intervention weeks; 9 weeks after study start)

• Satisfaction with the specific intervention components

  Last questionnaire of the study for each participant (post questionnaire right after the 8 intervention weeks; 9 weeks after study start)

• Needs assessment

  Last questionnaire of the study for each participant (post questionnaire right after the 8 intervention weeks; 9 weeks after study start)

Study Arms (1)

Intervention group

EXPERIMENTAL

This Group will be using the iPAL App for 8 Weeks

Behavioral: iPAL App

Interventions

iPAL App BEHAVIORAL

The intervention will have a duration of eight weeks. It is theory-based, will be delivered to participants' smartphones via the study app (except components 5 and 6), and comprises the following components: 1. Theory-based individualized feedback. 2. Self-generated motivational messages. 3. Motivation for habit formation through push messages. 4. Motivational images and videos that participants handed in or selected will be sent to them through the app. 5. Study-specific social media groups. Participants will be offered the option to participate in study-specific social media groups. 6. Posting motivational stories. A story of a person, who successfully changed his or her lifestyle to be more physically active and/or less sedentary, will be posted once a week in the study-specific social media groups.

Intervention group

Eligibility Criteria

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

You may qualify if:

• Cardiovascular disease patients
• Participating in cardiovascular rehabilitation OR having received the recommendation from a cardiologist to participate in cardiovascular rehabilitation and having refused
• Signing the informed consent form
• Owning a smartphone with internet access

You may not qualify if:

• Age under 18 years
• Having a contraindication for physical activity
• Existing or suspected non-fulfilment of the participation requirements
• Inability to follow the procedures of the study (e.g., by not speaking German, being unable to read or write, or severe cognitive impairment)
• Being in palliative care
• Being pregnant
• Having an assisted living situation
• Stroke patients

Sponsors & Collaborators

• Claudio Nigg: lead
• University of Bern: collaborator

Study Sites (1)

Institute of Sport Science, University of Bern

Bern, 3012, Switzerland

Location

Related Publications (23)

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MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Claudio Nigg, PhD

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Claudio Nigg

Model Details: The study is a one-armed pilot 8-week tailored intervention with a pre-post-design, as well as an intensive-longitudinal design with weekly measurements.

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: May 22, 2023
• Study Start: November 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)