- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03805126
Expanding the UTHealth Medical Legal Partnership to Improve Mental Health for Low-Income Individuals
4 novembre 2020 mis à jour par: Winston Liaw, The University of Texas Health Science Center, Houston
The aim of this study is to test whether participation of low-income patients with health-harming legal needs (HHLNs) in a medical legal partnership (MLP) results in improved mental health, improved quality of life, reduced utilization, and increased resolution of HHLNs.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
160
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Texas
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Houston, Texas, États-Unis, 77093
- Jensen Clinic
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- low-income individuals (Low-income is defined as earning less than 200% of the Federal Poverty Level)
- individuals with HHLNs
- English or Spanish speaking
Exclusion Criteria:
- self-identified as being at significant and immediate risk due to HHLNs (e.g., a situation that involves imminent risk to the patient such as domestic violence)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Medical Legal Partnership
With the medical legal partnership, lawyers are embedded in clinics, and lawyers consult with patients who are identified as having health-harming legal needs (HHLNs).
This arm will also receive usual care, which includes consultation with a social worker and a community health worker.
|
With the medical legal partnership, lawyers are embedded in clinics, and lawyers consult with patients who are identified as having health-harming legal needs (HHLNs).
This arm will also receive usual care, which includes consultation with a social worker and a community health worker.
Usual care includes consultation with a social worker and a community health worker.
|
Comparateur actif: Usual Care
Usual care includes consultation with a social worker and a community health worker.
|
Usual care includes consultation with a social worker and a community health worker.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Stress as assessed by the Perceived Stress Scale
Délai: baseline
|
The perceived stress scale consists of 10 items, with each item ranging from 0-4, for a total score range of 0-40.
A higher score indicates a worse outcome.
|
baseline
|
Stress as assessed by the Perceived Stress Scale
Délai: 3 months
|
The perceived stress scale consists of 10 items, with each item ranging from 0-4, for a total score range of 0-40.
A higher score indicates a worse outcome.
|
3 months
|
Stress as assessed by the Perceived Stress Scale
Délai: 6 months
|
The perceived stress scale consists of 10 items, with each item ranging from 0-4, for a total score range of 0-40.
A higher score indicates a worse outcome.
|
6 months
|
Stress as assessed by the Perceived Stress Scale
Délai: 12 months
|
The perceived stress scale consists of 10 items, with each item ranging from 0-4, for a total score range of 0-40.
A higher score indicates a worse outcome.
|
12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
Délai: baseline
|
The Generalized Anxiety Disorder scale consists of 7 items, with each item ranging from 0-3, for a total score range of 0-21.
A higher score indicates a worse outcome.
|
baseline
|
Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
Délai: 3 months
|
The Generalized Anxiety Disorder scale consists of 7 items, with each item ranging from 0-3, for a total score range of 0-21.
A higher score indicates a worse outcome.
|
3 months
|
Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
Délai: 6 months
|
The Generalized Anxiety Disorder scale consists of 7 items, with each item ranging from 0-3, for a total score range of 0-21.
A higher score indicates a worse outcome.
|
6 months
|
Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
Délai: 12 months
|
The Generalized Anxiety Disorder scale consists of 7 items, with each item ranging from 0-3, for a total score range of 0-21.
A higher score indicates a worse outcome.
|
12 months
|
Depression as assessed by the Center for Epidemiologic Studies Depression Scale
Délai: baseline
|
The Center for Epidemiologic Studies Depression Scale consists of 20 items, with each item ranging from 0-3, for a total score range of 0-60.
A higher score indicates a worse outcome.
|
baseline
|
Depression as assessed by the Center for Epidemiologic Studies Depression Scale
Délai: 3 months
|
The Center for Epidemiologic Studies Depression Scale consists of 20 items, with each item ranging from 0-3, for a total score range of 0-60.
A higher score indicates a worse outcome.
|
3 months
|
Depression as assessed by the Center for Epidemiologic Studies Depression Scale
Délai: 6 months
|
The Center for Epidemiologic Studies Depression Scale consists of 20 items, with each item ranging from 0-3, for a total score range of 0-60.
A higher score indicates a worse outcome.
|
6 months
|
Depression as assessed by the Center for Epidemiologic Studies Depression Scale
Délai: 12 months
|
The Center for Epidemiologic Studies Depression Scale consists of 20 items, with each item ranging from 0-3, for a total score range of 0-60.
A higher score indicates a worse outcome.
|
12 months
|
Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Délai: baseline
|
The Patient-Reported Outcomes Measurement Information System (PROMIS) consists of 29 items, with 28 of the items ranging from 1-5 and 1 item ranging from 0-10, for a total score range of 28-150.
A higher score indicates a worse outcome.
|
baseline
|
Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Délai: 3 months
|
The Patient-Reported Outcomes Measurement Information System (PROMIS) consists of 29 items, with 28 of the items ranging from 1-5 and 1 item ranging from 0-10, for a total score range of 28-150.
A higher score indicates a worse outcome.
|
3 months
|
Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Délai: 6 months
|
The Patient-Reported Outcomes Measurement Information System (PROMIS) consists of 29 items, with 28 of the items ranging from 1-5 and 1 item ranging from 0-10, for a total score range of 28-150.
A higher score indicates a worse outcome.
|
6 months
|
Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Délai: 12 months
|
The Patient-Reported Outcomes Measurement Information System (PROMIS) consists of 29 items, with 28 of the items ranging from 1-5 and 1 item ranging from 0-10, for a total score range of 28-150.
A higher score indicates a worse outcome.
|
12 months
|
Number of Urgent Care Visits
Délai: baseline
|
baseline
|
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Number of Urgent Care Visits
Délai: 3 months
|
3 months
|
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Number of Urgent Care Visits
Délai: 6 months
|
6 months
|
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Number of Urgent Care Visits
Délai: 12 months
|
12 months
|
|
Number of Emergency Department Visits
Délai: baseline
|
baseline
|
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Number of Emergency Department Visits
Délai: 3 months
|
3 months
|
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Number of Emergency Department Visits
Délai: 6 months
|
6 months
|
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Number of Emergency Department Visits
Délai: 12 months
|
12 months
|
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Number of Hospital Visits
Délai: baseline
|
baseline
|
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Number of Hospital Visits
Délai: 3 months
|
3 months
|
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Number of Hospital Visits
Délai: 6 months
|
6 months
|
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Number of Hospital Visits
Délai: 12 months
|
12 months
|
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Percentage of baseline health-harming legal needs that were resolved
Délai: baseline
|
baseline
|
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Percentage of baseline health-harming legal needs that were resolved
Délai: 3 months
|
3 months
|
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Percentage of baseline health-harming legal needs that were resolved
Délai: 6 months
|
6 months
|
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Percentage of baseline health-harming legal needs that were resolved
Délai: 12 months
|
12 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Winston Liaw, MD, MPH, The University of Texas Health Science Center, Houston
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
14 février 2019
Achèvement primaire (Réel)
11 septembre 2020
Achèvement de l'étude (Réel)
11 septembre 2020
Dates d'inscription aux études
Première soumission
11 janvier 2019
Première soumission répondant aux critères de contrôle qualité
11 janvier 2019
Première publication (Réel)
15 janvier 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
6 novembre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 novembre 2020
Dernière vérification
1 novembre 2020
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- HSC-MS-18-1037
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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