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L'essai clinique NCT07083895 (ECG) pour Cardiovascular Disease (CVD) Risk Factors est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Université de la santé et des sciences de l'OregonEmpowering Cardiovascular Health in Custodial Grandparents (ECG)
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L'étude clinique NCT07083895 (ECG) est un essai interventionnel pour Cardiovascular Disease (CVD) Risk Factors. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 octobre 2025, avec un objectif de 70 participants. Dirigé par l'Université de la santé et des sciences de l'Oregon, l'essai devrait être terminé d'ici le 30 juin 2028. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 24 juillet 2025.
Résumé succinct
In this study, the investigators will tailor an existing intervention (Rural Caregiver Heart Health Education (RICHH)) protocol and test its feasibility, acceptability, and initial effect with grandparent caregivers.
Titre officiel
Empowering Cardiovascular Health in Custodial Grandparents
Conditions
Cardiovascular Disease (CVD) Risk FactorsAutres identifiants de l'essai
- ECG
- STUDY00028858
Numéro NCT
Date de début (réel)
2025-10-01
Dernière mise à jour publiée
2025-07-24
Date de fin (estimée)
2028-06-30
Inscription (estimée)
70
Type d'essai
Interventionnel
PHASE
N/A
Statut
Pas encore en recrutement
Mots clés
Rural Caregiver Heart Health Education (RICHH)
Custodial grandparents
Grandparent caregivers
Cardiovascular disease (CVD) risk factors
Community health workers
Grandchildren
Custodial grandparents
Grandparent caregivers
Cardiovascular disease (CVD) risk factors
Community health workers
Grandchildren
Objectif principal
Prévention
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Simple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalModified RICHH Intervention The investigators will employ a re-designed RICHH intervention and determine its feasibility and acceptability with custodial grandparents. | Modified RICHH The RICHH intervention is an educational-behavioral and counseling intervention that promotes caregivers' knowledge, skills and motivation to engage in CVD risk reduction. The intervention is delivered individually to caregivers in their homes using video-conferencing technology on mini-iPads. The program consists of 12 weekly sessions \[30-45 minutes\] that will be held at the caregivers' preferred times. RICHH consists of 6 interactive modules (i.e., self-management for heart health, depressive symptom management, heart healthy eating, physical activity, co-morbid condition management, and adherence to medication and smoking cessation).
The modified RICHH intervention utilizes focus group outcomes to employ modifications needed to target custodial grandparents from varied backgrounds (e.g., high ACEs, SDoH groups). |
Comparateur actifStandard of Care The usual care control group will receive mini-iPads loaded with Caregiver and CVD risk reduction pamphlets in PDF format along with the associated links from the American Heart Association. Because the investigators may identify CVD risk factors in baseline testing in participants who do not know they have them, it would be unethical not to provide at least usual standard of care for these. Thus, all individuals enrolled in the study and in whom the investigators identify CVD risk factors will receive referral to a primary care provider for management of the CVD risk factors identified. | Standard de soins (SOC) Referral to primary care provider |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Number of participants who complete the intervention and follow-up | Feasibility is measured by the count of participants who complete the intervention and follow-up components of the study | 4 months after baseline and 6 months after baseline |
Percentage of participants who indicate acceptability of study intervention | Acceptability will be assessed in the domains of affective attitude, burden, opportunity costs, perceived effectiveness, and self-efficacy | 4 months after baseline |
Physical activity | Measured using ActiGraph GT9X Link devices. The ActiGraph algorithms generate accurate and reliable data on total energy expenditure (kcal/day). Participants will wear the devices over 7-day periods at each data collection point. For each participant, the average proportion of time per day in moderate-to-vigorous physical activity (MVPA), out of total time wearing the monitors, will be calculated. | At baseline, 4 months after baseline, and 6 months after baseline |
Food intake | Measured using the self-report Viocare Food Frequency Questionnaire. Data from Viocare will be used to generate Healthy Eating Index scores, which range from 0 to 100. Higher scores indicate better dietary quality. | At baseline, 4 months after baseline, and 6 months after baseline |
Body mass index | BMI (kg/m2) will be calculated from height and body weight measured | At baseline, 4 months after baseline, and 6 months after baseline |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Blood pressure | Measured by the average of three consecutive resting blood pressure measurements (both systolic and diastolic pressures). | At baseline, 4 months after baseline, and 6 months after baseline |
Lipids | Measured using non-fasting total cholesterol obtained via finger stick | At baseline, 4 months after baseline, and 6 months after baseline |
Hemoglobin A1c (HbA1c) | Measured using non-fasting HbA1c obtained via finger stick | At baseline, 4 months after baseline, and 6 months after baseline |
Nicotine exposure | Assessed via self-report of cigarette use/inhaled nicotine use, or secondhand smoke exposure. AHA Life's Essential 8 algorithm will generate a score (0-100), with lower scores indicating greater risk. | At baseline, 4 months after baseline, and 6 months after baseline |
Depressive symptoms | Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. | At baseline, 4 months after baseline, and 6 months after baseline |
Waist circumference | Waist circumference will be measured using a nonextensible tape. At least two independent measurements will be taken and averaged. | At baseline, 4 months after baseline, and 6 months after baseline |
Critères d'éligibilité
Grandparent (inclusion):
- Provides full-time care to at least one grandchild (< 18 years old) for at least 6 months, with no biological parent residing in the household or providing substantial care to the children
- Lives in Oregon
- Has English proficiency sufficient for informed consent and completion of study measures
- Provides signed informed consent
Grandparent (exclusion)
- Plans for transfer of care to other caregivers or setting for the next 12 months
- Has significant physical or emotional impairment, or psychiatric illness that might interfere with engagement in their own self-management or that is likely to result in their needing a caregiver in the next 12 months
- Chronic drug abuse
- Current active cancer (i.e., undergoing active treatment for cancer) other than isolated skin cancer
Université de la santé et des sciences de l'Oregon237 essais cliniques actifs à explorerInstitut national du cœur, du poumon et du sang, États-Unis758 essais cliniques actifs à explorerPartie responsable de l'essai
MinKyoung Song, Investigateur principal, Associate Professor, Oregon Health and Science University
Contact central de l'essai
Contact: MinKyoung Song, PhD, RN, 503-418-2518, [email protected]
1 Centres de l'essai dans 1 pays
Oregon
Oregon Health & Science University, Portland, Oregon, 97239, United States
MinKyoung Song, PhD, RN, Contact, 503-418-2518, [email protected]
Contact, [email protected]
MinKyoung Song, PhD, RN, Investigateur principal