Maintenance of Physical Activity After Cardiac Rehabilitation

Heart Failure Clinical Trial

— FAIR  

Official title:

Maintenance of Physical Activity After Cardiac Rehabilitation: a Feasibility Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05011994
• Other study ID #: EMN-2021-00020
• Secondary ID: EMN-2021-00020RE
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: April 2022
• Source: Slagelse Hospital
• Contact: Rune M Andersen, PhD
• Phone: +4529623522
• Email: ruma[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Physical activity is a key element in cardiac rehabilitation and prevention of cardiovascular mortality and hospitalizations. After cardiac rehabilitation programs end, physical activity levels and participation in continued cardiac rehabilitation declines. The aim of this study is to evaluate the feasibility a mobile health intervention with text messages and behavior change theory in patients with cardiovascular disease for a duration of 3 months after completion of a cardiac rehabilitation program. An intervention consisting of action planning, text messages, and coordinator support is tested in a feasibility trial design with 40 expected participants.

Description:

Physical activity is a key element in cardiac rehabilitation and prevention of cardiovascular mortality and hospitalizations. After cardiac rehabilitation programs end, physical activity levels and participation in continued cardiac rehabilitation declines.

The primary aim of this study is to evaluate the feasibility in terms of recruitment, retention, data completeness, intervention delivery and compliance, and acceptability of a mobile health intervention with text messages and behavior change theory in patients with cardiovascular disease for a duration of 3 months after completion of a cardiac rehabilitation program.

The study is a single-group multi-site feasibility trial. Participants will be recruited from phase II cardiac rehabilitation programs at Slagelse Hospital, the city of Slagelse (municipality), and Holbæk Hospital. Starting immediately after completion of cardiac rehabilitation, study participants will receive an intervention that consists of action planning, text messages, and coordinator support for a period of 12 weeks (see more details under 'Arms and Interventions'). The investigators base the intervention on a theoretical model of behavior change in the form of the Health Action Process Approach (HAPA). Behavior change techniques (BCTs) are used as part of the intervention. The intervention is an addition to standard practice and does not replace any existing treatment offers.

To evaluate the feasibility of the intervention and its readiness to be tested in a subsequent RCT design, the investigators have set progression criteria using a system of green (proceed to RCT), amber (amend when proceeding to RCT), or red (issue must be solved before proceeding to RCT). The progression criteria are listed under 'Primary Outcome Measures'.

Participants will wear accelerometers on thigh and wrist for 1 and 3 weeks, respectively, starting 1 week before end of cardiac rehabilitation. Baseline measurements and start of intervention is planned to be at the same time as cardiac rehabilitation ends. After 11 weeks of intervention, participants will attend a follow-up assessment, where participants will wear accelerometers on thigh and wrist again.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years.

• Participant in an exercise-based cardiac rehabilitation program in either hospital or municipality setting.

• Access to a personal mobile phone and Danish telephone number.

• Able to walk 3 meters without assistance.

Exclusion Criteria:

• Insufficient Danish language proficiency to read and understand text messages and questionnaires.

• Patients cognitively or mentally unable to participate.

• Terminal patients and patients with a life expectancy of less than 3 months.

Related Conditions & MeSH terms

• Arrythmia
• Cardiovascular Diseases
• Heart Arrest
• Heart Diseases
• Heart Failure
• Ischemia
• Myocardial Ischemia

Intervention

Behavioral:
• Maintenance intervention
The intervention consists of action planning, text messages, and coordinator support. At onset, each participant creates an action plan for physical activity with the help of a health professional: What types of physical activities? When and how often? Where and with who? 2 auto-generated text messages are sent weekly for a duration of 12 weeks. The first prompts physical activity. The second asks if plans were reached. If yes, an automatic reply with positive reinforcement is generated. If no, an automatic reply asks if the participant wants to be contacted. Participants are contacted by a coordinator either by answering text messages or if not answering the texts for a period of 2 weeks or more. Coordinator functions: Call participants replying to texts that they wish to be contacted Help participants establish contact to local activities involving physical activity Follow-up on and adjustment of action plan Offer guidance in physical activity

Locations

Country	Name	City	State
Denmark	Holbæk Hospital	Holbæk
Denmark	City of Slagelse (municipality)	Korsør
Denmark	Slagelse Hospital	Slagelse

Sponsors (5)

Lead Sponsor	Collaborator
Slagelse Hospital	City of Slagelse (municipality), Holbaek Sygehus, University College Copenhagen, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health-related quality of life, general	EQ-5D-5L evaluates health status in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated from 1 (best) to 5 (worst) and overall health is rated on a 0 to 100 VAS scale.	Change from baseline to 12 weeks
Other	Health-related quality of life, VAS subscale	EQ-5D-5L evaluates health status in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated from 1 (best) to 5 (worst) and overall health is rated on a 0 to 100 VAS scale.	Change from baseline to 12 weeks
Other	Health-related quality of life, heart-specific	HeartQoL is used to measure heart-specific quality of life in the past 4 weeks. Range from 0 (worst) to 42 (best) .	Change from baseline to 12 weeks
Other	Anxiety and depression	Hospital Anxiety and Depression Scale (HADS). HADS gives a score for each of anxiety and depression, each ranging from 0 (best) to 21 (worst).	Change from baseline to 12 weeks
Other	Physical function, self-reported	WHO Disability Assessment Schedule 2.0 (WHODAS 2.0),12-item version. WHODAS is a generic assessment instrument for health and disability. Range from 12 (no disability) to 60 (highest disability or loss of function).	Change from baseline to 12 weeks
Other	Comorbidity	Disease Burden: Morbidity Assessment by Self-Report used to evaluated a list of common chronic conditions affect the participants' daily activities. Each condition (that the participant has) is rated from 1 (not at all) to 5 (a lot) in regard to how much it limits daily activities.	Change from baseline to 12 weeks
Other	Self-efficacy, managing chronic disease	Self-efficacy of managing chronic disease 6 items scale. Score is calculated as the mean of 6 items, each scored from 1 (low self-efficacy) to 10 (high self-efficacy).	Change from baseline to 12 weeks
Other	Motivational Self-efficacy	Motivational self-efficacy, HAPA items by Schwartzer R., 2 items each rated on a scale from 1 (low self-efficacy) to 4 (high self-efficacy).	Change from baseline to 12 weeks
Other	Coping Self-efficacy	Coping self-efficacy, HAPA items by Schwartzer R., 2 items each rated on a scale from 1 (low self-efficacy) to 4 (high self-efficacy).	Change from baseline to 12 weeks
Other	Recovery Self-efficacy	Recovery self-efficacy, HAPA items by Schwartzer R., 2 items each rated on a scale from 1 (low self-efficacy) to 4 (high self-efficacy).	Change from baseline to 12 weeks
Primary	Recruitment	Green: Mean of =0.75 recruited participants per week per site; Amber: Mean of 0.5-0.74 recruited participants per week per site; Red: Mean of <0.5 recruited participants per week per site	Baseline
Primary	Attrition/retention through follow-up assessment session	Green: =80% retention of participants through follow up; Amber: 50-79% retention of participants through follow up; Red: <50% retention of participants through follow up	Up to 12 weeks
Primary	Accelerometer data completeness	Green: Accelerometer data from both baseline and follow-up available on =80% of completing participants; Amber: Data available on 50-79% of completing participants; Red: Data available on <50% of completing participants	Baseline
Primary	Accelerometer data completeness	Green: Accelerometer data from both baseline and follow-up available on =80% of completing participants; Amber: Data available on 50-79% of completing participants; Red: Data available on <50% of completing participants	12 weeks
Primary	Response rate on patient reported outcomes	Green: =90% of participants attending baseline and follow-up assessment return patient reported outcomes; Amber: 75-89% of patients attending baseline and follow-up assessment return patient reported outcomes; Red: <75% of participants attending baseline and follow-up assessment return patient reported outcomes	Baseline
Primary	Response rate on patient reported outcomes	Green: =90% of participants attending baseline and follow-up assessment return patient reported outcomes; Amber: 75-89% of patients attending baseline and follow-up assessment return patient reported outcomes; Red: <75% of participants attending baseline and follow-up assessment return patient reported outcomes	12 weeks
Primary	Coordinator time spent, minutes per participant throughout the intervention	Green: Mean coordinator time spent of =30 minutes per participant; Amber: Mean coordinator time spent of 31-60 minutes per participant; Red: Mean coordinator time spent of >60 minutes per participant	12 weeks
Primary	Response rate (adherence) to weekly follow-up messages	Green: =75% of patients respond to at least 75% of messages; Amber: 50-74% of patients respond to at least 75% of messages; Red: <50% of patients respond to at least 75% of messages	12 weeks
Primary	Acceptability of text message component, single item	Green: =75% of participants find text messages acceptable; Amber: 50-74% of participants find text messages acceptable; Red: <50% of participants find text messages acceptable	12 weeks
Secondary	Physical activity, objectively measured	Measured with thigh and wrist accelerometers	Change from baseline to 12 weeks
Secondary	Physical function, walking	6 minute walking test	Change from baseline to 12 weeks
Secondary	Physical function, sit-to-stand	30-second sit-to-stand test	Change from baseline to 12 weeks
Secondary	Physical activity, subjectively measured	The International Physical Activity Questionnaire (IPAQ) is used to measure physical activity in the past 7 days. 0 is minimum (completely inactivty).	Change from baseline to 12 weeks

External Links

•   Link to published study protocol