ID

44913

Description

Adapted from the BMJopen after: Andersen RM, Skou ST, Clausen MB, et al Maintenance of physical activity after cardiac rehabilitation (FAIR): study protocol for a feasibility trial BMJ Open 2022;12:e060157. doi: 10.1136/bmjopen-2021-060157 Copyright information: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ Abstract Introduction To enhance health and prevent secondary consequences for patients with cardiovascular disease (CVD), maintenance of an active lifestyle following participation in cardiac rehabilitation (CR) is important. However, levels of physical activity often decrease after completion of a structured CR programme. Models that support long-term behaviour change with a sustained level of physical activity are imperative. The aim of this study is to evaluate the feasibility of a mobile health intervention based on the Health Action Process Approach theoretical model of behaviour change in patients with CVD for 3 months after completion of a CR programme. Methods and analysis In a feasibility trial design, we will recruit 40 participants from CR programmes at Slagelse Hospital, the City of Slagelse (municipality), or Holbæk Hospital. After completing the standard structured CR programme, each participant will create an action plan for physical activity together with a physiotherapist. Following that, participants are sent 2 weekly text messages for 3 months. The first text message prompts physical activity, and the second will check if the action plan has been followed. If requested by participants, a coordinator will call and guide the physical activities behaviour. The feasibility of this maintenance intervention is evaluated based on predefined progression criteria. Physical activity is measured with accelerometers at baseline and at 3 months follow-up. Ethics and dissemination Study approval was waived (EMN-2021-00020) by the Research Ethics Committee of Region Zealand, Denmark. Study results will be made public and findings disseminated to patients, health professionals, decision-makers, researchers and the public. Trial registration number NCT05011994.

Link

http://creativecommons.org/licenses/by-nc/4.0/

Keywords

  1. 4/7/22 4/7/22 - Dr. Christian Niklas
Copyright Holder

Andersen RM, Skou ST, Clausen MB, et al

Uploaded on

April 7, 2022

DOI

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License

Creative Commons BY-NC 4.0

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Maintenance of physical activity after cardiac rehabilitation (FAIR): study protocol for a feasibility trial

PATIENT-REPORTED OUTCOMES (planned RCT outcomes)

  1. StudyEvent: Screening - Maintenance of physical activity after cardiac rehabilitation (FAIR): study protocol for a feasibility trial
    1. FEASIBILITY OUTCOMES
    2. PATIENT CHARACTERISTICS AND OTHER OUTCOMES
  2. StudyEvent: Baseline - Maintenance of physical activity after cardiac rehabilitation (FAIR): study protocol for a feasibility trial
    1. FEASIBILITY OUTCOMES
    2. CLINICALLY ASSESSED OUTCOMES (planned RCT outcomes)
    3. PATIENT-REPORTED OUTCOMES (planned RCT outcomes)
    4. PATIENT CHARACTERISTICS AND OTHER OUTCOMES
  3. StudyEvent: Continuous - Maintenance of physical activity after cardiac rehabilitation (FAIR): study protocol for a feasibility trial
    1. FEASIBILITY OUTCOMES
  4. StudyEvent: 3 months - Maintenance of physical activity after cardiac rehabilitation (FAIR): study protocol for a feasibility trial
    1. FEASIBILITY OUTCOMES
    2. CLINICALLY ASSESSED OUTCOMES (planned RCT outcomes)
    3. PATIENT-REPORTED OUTCOMES (planned RCT outcomes)
    4. PATIENT CHARACTERISTICS AND OTHER OUTCOMES
Outcomes
Description

Outcomes

Self-reported physical activity - International Physical Activity Questionnaire (IPAQ)
Description

Self-reported physical activity

Data type

integer

Alias
UMLS CUI [1,1]
C4319956
Health-related quality of life - EQ-5D-5L; HeartQOL
Description

Health-related quality of life

Data type

integer

Alias
UMLS CUI [1,1]
C2733251
UMLS CUI [2,1]
C0018787
UMLS CUI [2,2]
C0518214
Comorbidity - Disease Burden: Morbidity Assessment by Self-Report
Description

Comorbidity

Data type

integer

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2828008
UMLS CUI [1,3]
C2700446
Anxiety and depression - Hospital Anxiety and Depression Scale (HADS)
Description

Anxiety and depression

Data type

integer

Alias
UMLS CUI [1,1]
C3539657
Physical function self-reported - WHODAS 2.0 12-item version
Description

Physical function, self-reported

Data type

integer

Alias
UMLS CUI [1,1]
C4321496
Self-efficacy of managing chronical disease - 6-item scale
Description

Self-efficacy of managing chronical disease

Data type

integer

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0600564
UMLS CUI [1,3]
C0008679
Importance of being physically active
Description

Purpose-designed item(s)

Data type

integer

Alias
UMLS CUI [1,1]
C0030971
UMLS CUI [1,2]
C0026606
UMLS CUI [1,3]
C3898777
Motivational self-efficacy - 2-item questionnaire, HAPA (40)
Description

Motivational self-efficacy

Data type

integer

Alias
UMLS CUI [1,1]
C0600564
UMLS CUI [1,2]
C0026605
Coping self-efficacy - 2-item questionnaire, HAPA (40)
Description

Coping self-efficacy

Data type

integer

Alias
UMLS CUI [1,1]
C0600564
UMLS CUI [1,2]
C0009967
Recovery self-efficacy - 2-item questionnaire, HAPA (40)
Description

Recovery self-efficacy

Data type

integer

Alias
UMLS CUI [1,1]
C0600564
UMLS CUI [1,2]
C2004454
Perceived COVID limitations to physical activity
Description

Purpose-designed item(s)

Data type

integer

Alias
UMLS CUI [1,1]
C5203670
UMLS CUI [1,2]
C0030971
UMLS CUI [1,3]
C0449295
UMLS CUI [1,4]
C0026606
Participant experience/satisfaction
Description

Purpose-designed item(s)

Data type

integer

Alias
UMLS CUI [1,1]
C0242428
UMLS CUI [1,2]
C1997894
UMLS CUI [2,1]
C1997894
UMLS CUI [2,2]
C0596545
Other treatment during intervention period: rehabilitation; exercise; physical activity
Description

Purpose-designed item(s)

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0034991
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0026606
Types of physical activities undertaken
Description

Purpose-designed item(s)

Data type

text

Alias
UMLS CUI [1,1]
C0026606
UMLS CUI [1,2]
C2348235
Frequency reading text messages
Description

Purpose-designed item(s)

Data type

float

Alias
UMLS CUI [1,1]
C0439603
UMLS CUI [1,2]
C3178910
UMLS CUI [1,3]
C0034754
Hospitalization; Cause of hospitalization; Hospital contacts
Description

Purpose-designed item(s)

Data type

text

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [2,1]
C1830395
UMLS CUI [3,1]
C0019994
UMLS CUI [3,2]
C0545082

Similar models

PATIENT-REPORTED OUTCOMES (planned RCT outcomes)

  1. StudyEvent: Screening - Maintenance of physical activity after cardiac rehabilitation (FAIR): study protocol for a feasibility trial
    1. FEASIBILITY OUTCOMES
    2. PATIENT CHARACTERISTICS AND OTHER OUTCOMES
  2. StudyEvent: Baseline - Maintenance of physical activity after cardiac rehabilitation (FAIR): study protocol for a feasibility trial
    1. FEASIBILITY OUTCOMES
    2. CLINICALLY ASSESSED OUTCOMES (planned RCT outcomes)
    3. PATIENT-REPORTED OUTCOMES (planned RCT outcomes)
    4. PATIENT CHARACTERISTICS AND OTHER OUTCOMES
  3. StudyEvent: Continuous - Maintenance of physical activity after cardiac rehabilitation (FAIR): study protocol for a feasibility trial
    1. FEASIBILITY OUTCOMES
  4. StudyEvent: 3 months - Maintenance of physical activity after cardiac rehabilitation (FAIR): study protocol for a feasibility trial
    1. FEASIBILITY OUTCOMES
    2. CLINICALLY ASSESSED OUTCOMES (planned RCT outcomes)
    3. PATIENT-REPORTED OUTCOMES (planned RCT outcomes)
    4. PATIENT CHARACTERISTICS AND OTHER OUTCOMES
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Outcomes
Self-reported physical activity
Item
Self-reported physical activity - International Physical Activity Questionnaire (IPAQ)
integer
C4319956 (UMLS CUI [1,1])
Health-related quality of life
Item
Health-related quality of life - EQ-5D-5L; HeartQOL
integer
C2733251 (UMLS CUI [1,1])
C0018787 (UMLS CUI [2,1])
C0518214 (UMLS CUI [2,2])
Comorbidity
Item
Comorbidity - Disease Burden: Morbidity Assessment by Self-Report
integer
C0009488 (UMLS CUI [1,1])
C2828008 (UMLS CUI [1,2])
C2700446 (UMLS CUI [1,3])
Anxiety and depression
Item
Anxiety and depression - Hospital Anxiety and Depression Scale (HADS)
integer
C3539657 (UMLS CUI [1,1])
Physical function, self-reported
Item
Physical function self-reported - WHODAS 2.0 12-item version
integer
C4321496 (UMLS CUI [1,1])
Self-efficacy of managing chronical disease
Item
Self-efficacy of managing chronical disease - 6-item scale
integer
C0681889 (UMLS CUI [1,1])
C0600564 (UMLS CUI [1,2])
C0008679 (UMLS CUI [1,3])
Importance of being physically active
Item
Importance of being physically active
integer
C0030971 (UMLS CUI [1,1])
C0026606 (UMLS CUI [1,2])
C3898777 (UMLS CUI [1,3])
Motivational self-efficacy
Item
Motivational self-efficacy - 2-item questionnaire, HAPA (40)
integer
C0600564 (UMLS CUI [1,1])
C0026605 (UMLS CUI [1,2])
Coping self-efficacy
Item
Coping self-efficacy - 2-item questionnaire, HAPA (40)
integer
C0600564 (UMLS CUI [1,1])
C0009967 (UMLS CUI [1,2])
Recovery self-efficacy
Item
Recovery self-efficacy - 2-item questionnaire, HAPA (40)
integer
C0600564 (UMLS CUI [1,1])
C2004454 (UMLS CUI [1,2])
Perceived COVID limitations to physical activity
Item
Perceived COVID limitations to physical activity
integer
C5203670 (UMLS CUI [1,1])
C0030971 (UMLS CUI [1,2])
C0449295 (UMLS CUI [1,3])
C0026606 (UMLS CUI [1,4])
Participant experience/satisfaction
Item
Participant experience/satisfaction
integer
C0242428 (UMLS CUI [1,1])
C1997894 (UMLS CUI [1,2])
C1997894 (UMLS CUI [2,1])
C0596545 (UMLS CUI [2,2])
Other treatment during intervention
Item
Other treatment during intervention period: rehabilitation; exercise; physical activity
text
C0205394 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0034991 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0026606 (UMLS CUI [2,3])
Types of physical activities undertaken
Item
Types of physical activities undertaken
text
C0026606 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Frequency reading text messages
Item
Frequency reading text messages
float
C0439603 (UMLS CUI [1,1])
C3178910 (UMLS CUI [1,2])
C0034754 (UMLS CUI [1,3])
Hospitalization
Item
Hospitalization; Cause of hospitalization; Hospital contacts
text
C0019993 (UMLS CUI [1,1])
C1830395 (UMLS CUI [2,1])
C0019994 (UMLS CUI [3,1])
C0545082 (UMLS CUI [3,2])

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