Clinical trial NCT03810612: Patient-reported Outcomes After Percutaneous Coronary Intervention
Official title: Continuity of Care, Adherence to Treatment and Self-reported Health After Percutaneous Coronary Intervention (CONCARD): a Patient-centered Care Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Keywords: Adherence to treatment
Continuity of care
Health literacy
Patient involvement
Patient preferences
Percutaneous coronary intervention
Rehabilitation
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Stavanger HF
name: Oslo University Hospital
name: Zealand University Hospital
name: Odense University Hospital
name: Rigshospitalet, Denmark
name: Herlev and Gentofte Hospital
name: Western Norway University of Applied Sciences
First posted: 2019-01-18
Enrollment: 3417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone percutaneous coronary intervention will be included prospectively at each percutaneous coronary intervention centre.

Brief summary: The main objective is to investigate i) continuity of care, ii) health literacy and self-management, iii) adherence to treatment, and iv) patient preferences, healthcare utilization and costs, and to determine associations with future short- and long-term health outcomes in patients after percutaneous coronary intervention.

Detailed description: CONCARD will use multiple designs. (1) An inductive exploratory design including in-depth interviews on patients' experiences of healthcare delivery will provide a context for the quantitative data to develop the content of the cohort study and trial intervention. (2) A prospective cohort design with a 1-year follow-up period will include data on patient-reported outcomes, and a 10-year follow-up for adverse events. In translation and adaptation of patient-reported outcome measures, a methodological design will be applied. (3) A discrete choice experiment will investigate patient preferences for aftercare and cardiac rehabilitation.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing percutaneous coronary intervention
* ≥ 18 years of age
* Living at home at the time of inclusion.

Exclusion Criteria:

* Patients who do not speak Norwegian/Danish
* Patients who are unable to fill in the questionnaires due to reduced capacities
* Institutionalized patients
* Patients with expected lifetime less than one year
* Percutaneous coronary intervention without stent implantation
* Patients undergoing percutaneous coronary intervention related to Transcatheter Aortic Valve Implantation or Mitraclip examination
* Previous enrollment in CONCARD (readmissions).

Primary outcomes:
measure: Continuity of care
timeFrame: 2 months
measure: Evaluation of the quality of healthcare delivery
timeFrame: 2 months
measure: Change in eHealth literacy
timeFrame: 2 months, 12 months
measure: Change in health literacy
timeFrame: 2 months, 12 months
measure: Patient knowledge, skill, and confidence for self-management.
timeFrame: 6 months
measure: Change in beliefs and perceptions about medicines and treatment
timeFrame: 2 months, 6 months, 12 months
measure: Change in self-reported adherence to medicines
timeFrame: 2 months, 6 months, 12 months
measure: Change in medication use
timeFrame: 2 months, 6 months, 12 months
measure: Health care utilization
timeFrame: Up to 24 months
measure: Health care (associated) costs
timeFrame: Up to 24 months
Secondary outcomes:
measure: Time to readmission to hospital
timeFrame: 30-days, 3 months, 6 months, 12 months, up to 10 years
measure: Time to death
timeFrame: 30-days, 3 months, 6 months, 12 months, up to 10 years
measure: Change in anxiety and depression
timeFrame: 2 months, 6 months, 12 months
measure: Change in self-reported health
timeFrame: 2 months, 6 months, 12 months
measure: Change in chest pain
timeFrame: 2 months, 6 months, 12 months
measure: Change in fatigue
timeFrame: 2 months, 6 months,12 months
measure: Frailty status
timeFrame: 12 months
measure: Patient preferences in discrete choice experiments
timeFrame: 3 months
measure: Health related quality of life
timeFrame: 12 months
measure: Change in physical and mental dimensions of health.
timeFrame: 2 months, 6 months, 12 months
measure: Change in health status following myocardial infarction
timeFrame: 2 months, 6 months, 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Herlev and Gentofte Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Copenhagen
city: Odense
country: Denmark
facility: Odense University Hospital
city: Roskilde
country: Denmark
facility: Zealand University Hospital
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Tone M Norekvål, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramstad KJ, Brors G, Pettersen TR, Deaton C, Palm P, Rotevatn S, Wentzel-Larsen T, Norekval TM. eHealth technology use and eHealth literacy after percutaneous coronary intervention. Eur J Cardiovasc Nurs. 2023 Jul 19;22(5):472-481. doi: 10.1093/eurjcn/zvac087.
citation: Brors G, Wentzel-Larsen T, Dalen H, Hansen TB, Norman CD, Wahl A, Norekval TM; CONCARD Investigators. Psychometric Properties of the Norwegian Version of the Electronic Health Literacy Scale (eHEALS) Among Patients After Percutaneous Coronary Intervention: Cross-Sectional Validation Study. J Med Internet Res. 2020 Jul 28;22(7):e17312. doi: 10.2196/17312.
citation: Norekval TM, Allore HG, Bendz B, Bjorvatn C, Borregaard B, Brors G, Deaton C, Falun N, Hadjistavropoulos H, Hansen TB, Igland S, Larsen AI, Palm P, Pettersen TR, Rasmussen TB, Schjott J, Sogaard R, Valaker I, Zwisler AD, Rotevatn S; CONCARD Investigators. Rethinking rehabilitation after percutaneous coronary intervention: a protocol of a multicentre cohort study on continuity of care, health literacy, adherence and costs at all care levels (the CONCARDPCI). BMJ Open. 2020 Feb 12;10(2):e031995. doi: 10.1136/bmjopen-2019-031995.