Coronary Artery Disease Clinical Trial
Official title:
Enhancing Cardiac Rehabilitation Adherence Through Home-based Rehabilitation and Behavioral Nudges: ERA Nudge
NCT number | NCT03834155 |
Other study ID # | 18-1290 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2019 |
Est. completion date | September 30, 2023 |
Adherence to cardiac rehabilitation is poor, and worse for minorities, women, and those with lower levels of education. Patients less likely to be referred to and complete cardiac rehab are at highest risk of adverse outcomes and thus have the most to gain from participation in cardiac rehab. To improve participation, healthcare systems need to limit barriers to enrollment and promote adherence to rehabilitation.
Status | Recruiting |
Enrollment | 280 |
Est. completion date | September 30, 2023 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Diagnosis of acute myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, valvular heart surgery, chronic stable angina, and/or chronic stable heart failure with left ventricular systolic dysfunction. - 18 year of age or older - Access to a cell phone with text messaging capability - English or Spanish speaking Exclusion Criteria: - Medical director's decision based on high-risk assessment - Enrolled in hospice or palliative care - Being intoxicated or otherwise unable to consent to participate |
Country | Name | City | State |
---|---|---|---|
United States | Denver Health and Hospital Authority | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
Denver Health and Hospital Authority |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence to cardiovascular rehabilitation measured by self-report in the Movn Application or through EHR/exercise physiologist report in RedCap | Attendance for 4 weeks (8 or more) exercise sessions for hospital-based CR or logging exercise data for 4 weeks for home-based rehabilitation. | 12 weeks | |
Secondary | Active enrollment of 280 DH participants | Attending one visit following baseline visit or logging exercise data at least once for home-based CR. | 3.5 yrs | |
Secondary | Completion of cardiovascular rehabilitation as defined by attending or logging 18 exercise sessions | Attending or logging 18 exercise sessions | 12 weeks | |
Secondary | Exercise capacity measured by a 6-minute walk test. | Exercise capacity will be measured at the index visit, 6 weeks, 12 weeks. | 12 weeks | |
Secondary | Patient activation and engagement will be measured using the 13-item Patient Activation Measure (PAM) | The low-literacy version of the 13-item Patient Activation Measure (PAM), both in English and Spanish, will be used to assess the effect of the intervention on patient activation. This validated and predictive tool assesses patient knowledge, skill and confidence in self-management. A single point change in PAM score is clinically meaningful and increases in the PAM are associated with increased self-management behavior. The PAM will be measured at the index visit, 6 weeks, 12 weeks. | 12 weeks | |
Secondary | Reported quality of life measured by Ferrans and Powers Quality of Life Index | The Ferrans and Powers Quality of Life Index (QLI) will be used to assess quality of life. The QLI is a 35 question instrument that uses a 6 point scale ranging from "very unimportant (lower end of the scale)" to "very important (higher end of the scale)". The outcomes of these scales are averaged to compute the total score. The QLI is valid, reliable, sensitive to change in both CR and PR populations, and is available in English and in Spanish. The QLI will be administered at the index visit, 6 weeks and 12 weeks. | 12 weeks | |
Secondary | Number of participants hospitalized over four months using EHR review and ICD-10s | All-cause hospitalizations will be ascertained via the EHR using ICD-10 codes. Follow-up for hospitalizations will occur through 6 months. | 6 months | |
Secondary | Number of participants who attend or log of 36 cardiovascular rehabilitation sessions measured by self-report in the Movn Application or through EHR/exercise physiologist report in RedCap | Attending or logging 36 exercise sessions. | 12 weeks | |
Secondary | Type of healthcare utilization by individual participants, defined by routine clinical visits. Urgent care and emergency department visits will be measured using EHR. | Healthcare utilization, defined by routine clinical visits. Urgent care and emergency department visits will be measured using EHR. | 6 months | |
Secondary | Safety measures to track injury from exercise will be assessed using EHR | Injury from exercise will be assessed using EHR including hospitalizations, emergency department visits, urgent care visits and mortality safety endpoints.
They will be captured at the time of occurrence and records will be reviewed by the DSMB. |
12 weeks | |
Secondary | Socioeconomic and clinical data will be collected from EHR. | Sociodemographic and clinical data will be collected from DH registration files including age, gender, self-reported race/ethnicity, primary language preference, comorbid diagnoses (hypertension, diabetes, chronic kidney disease, depression, substance abuse), measures of disease severity (left ventricular ejection fraction, FEV1) and medications. | 3.5 yrs |
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