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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05370014 |
|
Full text link
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Aug. 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
magwoodg@sc.edu |
|
Registration date
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
2022-05-11 |
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Recruitment status
Last imported at : May 23, 2023, 4 p.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : May 23, 2023, 4 p.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
Long covid |
|
Inclusion criteria
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
inclusion criteria: covid-19 survivor inclusion criteria african american male and female living in a medically underserved area of south carolina; rural ≥ 18 years and above a history of a covid-19-associated hospitalization since march 11th 2020 a previous diagnosis of one or more of the following conditions: type 2 diabetes, hypertension, cardiovascular disease, chronic kidney disease, or stroke (>3 months) -carepartner inclusion criteria male and female ≥ 18 years and above must live on same property or community preferably within 20-mile radius as the survivor primarily responsible for care provision/ care support in the home (i.e., is not paid for services) |
|
Exclusion criteria
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
survivor and carepartner exclusion criteria • enrolled in related clinical trials |
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Number of arms
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Sept. 1, 2022, 10 p.m. Source : ClinicalTrials.gov |
University of South Carolina |
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Inclusion age min
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : May 23, 2023, 4 p.m. Source : ClinicalTrials.gov |
United States |
|
Type of patients
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
Patients recovered from covid |
|
Severity scale
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
500 |
|
primary outcome
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
Change in patient-reported outcomes measurement information system (PROMIS) Global Health Scale |
|
Notes
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
Phase 4 |
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Arms
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM) is 14-week, nurse coordinated, Community Health Worker (CHW) supported telehealth intervention structure. After baseline assessment, dyads randomized to the intervention group (n= 125 dyads) will have two planning sessions (over 2 weeks) followed by eight topic-guided sessions delivered by a member of the RN-CHW team over 12 weeks (weekly the first 4 weeks, then bi-weekly), Follow up assessments will occur at month 4 and month 7.", "treatment_id": 1983, "treatment_name": "Educational instructions", "treatment_type": "Education", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "After baseline assessment, dyads randomized to the attention control group (n= 125 dyads) will receive monthly (3 in total; 7-10 min each) scripted phone calls on focused on general health risks and health promotion. Monthly telephone calls will cover readily accessible evidence-based public health messaging from the Centers for Disease Control and Prevention (CDC) Your Health and Medical University of South Carolina (MUSC) Epidemiology Intelligence Project community facing websites related to COVID-19 mitigation such as risk reduction and prevention strategies including flu vaccines, asymptomatic spread, and contact tracing. Follow up assessments will occur at month 4 and month 7.", "treatment_id": 1983, "treatment_name": "Educational instructions", "treatment_type": "Education", "pharmacological_treatment": "Non pharmacological treatment"}] |