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  1. 1. Klinische Studie
    1. 1.1. Ein-/Ausschluss
    1. 1.2. Anamnese
    1. 1.3. Körperliche Untersuchung
    1. 1.4. Score
    1. 1.5. Apparative Diagnostik
    1. 1.6. Labor
    1. 1.7. Pathologie/Histologie
    1. 1.8. Aufklärung/Einverständis
    1. 1.9. Therapie
    1. 1.10. Operationsbericht
    1. 1.11. Unerwünschtes Ereignis
    1. 1.12. Follow-Up
  2. 2. Routinedokumentation
  3. 3. Register-/Kohortenstudien
  4. 4. Qualitätssicherung
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Maintenance of physical activity after cardiac rehabilitation (FAIR): study protocol for a feasibility trial - PATIENT CHARACTERISTICS AND OTHER OUTCOMES

- 07.04.22 - 11 Formulare, 1 Itemgruppe, 1 Datenelement, 1 Sprache
Itemgruppe: Outcomes
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.

PATIENT CHARACTERISTICS AND OTHER OUTCOMES

1 Itemgruppe 14 Datenelemente

CLINICALLY ASSESSED OUTCOMES

1 Itemgruppe 10 Datenelemente

CLINICALLY ASSESSED OUTCOMES

1 Itemgruppe 9 Datenelemente

PATIENT-REPORTED OUTCOMES

1 Itemgruppe 16 Datenelemente

PATIENT-REPORTED OUTCOMES

1 Itemgruppe 10 Datenelemente

FEASIBILITY OUTCOMES

1 Itemgruppe 6 Datenelemente

Eligibility Testicular Cancer NCT02276430

- 28.09.21 - 1 Formular, 3 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Additional inclusion criteria for participating in the cardiometabolic risk inventory study, Exclusion Criteria
TACkLE Study - Tackling Adverse Chemotherapy-associated Late Effects; ODM derived from: https://clinicaltrials.gov/show/NCT02276430

Eligibility Cardiovascular Disease NCT01163175

- 27.09.21 - 1 Formular, 2 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Study of the Impact of Trans Fatty Acids From Dairy Products on Cardiovascular Risk Factors; ODM derived from: https://clinicaltrials.gov/show/NCT01163175

Eligibility Cardiovascular Disease NCT00860925

- 27.09.21 - 1 Formular, 2 Itemgruppen, 30 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
PeriOperative ISchemic Evaluation-2 Pilot; ODM derived from: https://clinicaltrials.gov/show/NCT00860925

Eligibility Cardiovascular Disease NCT01000194

- 27.09.21 - 1 Formular, 2 Itemgruppen, 15 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Acute Fatty Acid Intervention Study (AFAST); ODM derived from: https://clinicaltrials.gov/show/NCT01000194

Eligibility Cardiovascular Disease NCT01178060

- 27.09.21 - 1 Formular, 2 Itemgruppen, 13 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
The Effectiveness of Personalized Stroke Risk Communication; ODM derived from: https://clinicaltrials.gov/show/NCT01178060

Phlebotomy Cardiovascular Health Study (CHS)

- 20.09.21 - 1 Formular, 3 Itemgruppen, 14 Datenelemente, 1 Sprache
Itemgruppen: Adminstrative data, Phlebotomy, Date of interview
Documentation part: Record 12 Baseline Phlebotomy The Cardiovascular Health Study (CHS) was initiated by the National Heart, Lung and Blood Institute (NHLBI) in 1987 to determine the risk factors for development and progression of cardiovascular disease (CVD) in older adults, with an emphasis on subclinical measures. The study recruited 5,888 adults aged 65 or older at entry in four U.S. communities and conducted extensive annual clinical exams between 1989-1999 along with semi-annual phone calls, events adjudication, and subsequent data analyses and publications. Additional data were collected by studies ancillary to CHS. With the exception of annual clinic visits, these activities are still ongoing. Data obtained from: https://chs-nhlbi.org/ Permission granted by: Erika Enright.

Medications Cardiovascular Health Study (CHS)

- 20.09.21 - 1 Formular, 4 Itemgruppen, 24 Datenelemente, 1 Sprache
Itemgruppen: Section A Medication Reception, Section B Prescription Medications, Selection C Selected Over-The-Counter Medications and Supplements, Date of interview
Documentation part: Record 6 Medications The Cardiovascular Health Study (CHS) was initiated by the National Heart, Lung and Blood Institute (NHLBI) in 1987 to determine the risk factors for development and progression of cardiovascular disease (CVD) in older adults, with an emphasis on subclinical measures. The study recruited 5,888 adults aged 65 or older at entry in four U.S. communities and conducted extensive annual clinical exams between 1989-1999 along with semi-annual phone calls, events adjudication, and subsequent data analyses and publications. Additional data were collected by studies ancillary to CHS. With the exception of annual clinic visits, these activities are still ongoing. Data obtained from: https://chs-nhlbi.org/ Permission granted by: Erika Enright.

Eligibility Cardiovascular Health Study (CHS)

- 20.09.21 - 1 Formular, 3 Itemgruppen, 82 Datenelemente, 1 Sprache
Itemgruppen: Adminstrative data, Eligibility Form, Date of interview
Documentation part: Record 1 Eligibility The Cardiovascular Health Study (CHS) was initiated by the National Heart, Lung and Blood Institute (NHLBI) in 1987 to determine the risk factors for development and progression of cardiovascular disease (CVD) in older adults, with an emphasis on subclinical measures. The study recruited 5,888 adults aged 65 or older at entry in four U.S. communities and conducted extensive annual clinical exams between 1989-1999 along with semi-annual phone calls, events adjudication, and subsequent data analyses and publications. Additional data were collected by studies ancillary to CHS. With the exception of annual clinic visits, these activities are still ongoing. Data obtained from: https://chs-nhlbi.org/ Permission granted by: Erika Enright.

Years 6-9 Medical & Personal History Cardiovascular Health Study (CHS)

- 20.09.21 - 1 Formular, 1 Itemgruppe, 314 Datenelemente, 1 Sprache
Itemgruppe: medical history
Documentation part: Record 59 Years 6-9 Medical & Personal History The Cardiovascular Health Study (CHS) was initiated by the National Heart, Lung and Blood Institute (NHLBI) in 1987 to determine the risk factors for development and progression of cardiovascular disease (CVD) in older adults, with an emphasis on subclinical measures. The study recruited 5,888 adults aged 65 or older at entry in four U.S. communities and conducted extensive annual clinical exams between 1989-1999 along with semi-annual phone calls, events adjudication, and subsequent data analyses and publications. Additional data were collected by studies ancillary to CHS. With the exception of annual clinic visits, these activities are still ongoing. Data obtained from: https://chs-nhlbi.org/ Permission granted by: Erika Enright.

Eligibility Cardiovascular Disease NCT00535886

- 20.09.21 - 1 Formular, 2 Itemgruppen, 13 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
The Effects of Natural Versus Man-Made Trans Fatty Acids on Lipoprotein Profiles: A Pilot Study; ODM derived from: https://clinicaltrials.gov/show/NCT00535886

Eligibility Cardiovascular Diseases NCT00627653

- 20.09.21 - 1 Formular, 2 Itemgruppen, 12 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Effect of a PPAR-Alpha Agonist on the Age Related Changes in Myocardial Metabolism and Mechanical Function; ODM derived from: https://clinicaltrials.gov/show/NCT00627653

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