- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03805126
Expanding the UTHealth Medical Legal Partnership to Improve Mental Health for Low-Income Individuals
4. November 2020 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
160
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Texas
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Houston, Texas, Vereinigte Staaten, 77093
- Jensen Clinic
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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.
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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.
|
Aktiver Komparator: Usual Care
Usual care includes consultation with a social worker and a community health worker.
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Usual care includes consultation with a social worker and a community health worker.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Stress as assessed by the Perceived Stress Scale
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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.
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12 months
|
Number of Urgent Care Visits
Zeitfenster: baseline
|
baseline
|
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Number of Urgent Care Visits
Zeitfenster: 3 months
|
3 months
|
|
Number of Urgent Care Visits
Zeitfenster: 6 months
|
6 months
|
|
Number of Urgent Care Visits
Zeitfenster: 12 months
|
12 months
|
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Number of Emergency Department Visits
Zeitfenster: baseline
|
baseline
|
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Number of Emergency Department Visits
Zeitfenster: 3 months
|
3 months
|
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Number of Emergency Department Visits
Zeitfenster: 6 months
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6 months
|
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Number of Emergency Department Visits
Zeitfenster: 12 months
|
12 months
|
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Number of Hospital Visits
Zeitfenster: baseline
|
baseline
|
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Number of Hospital Visits
Zeitfenster: 3 months
|
3 months
|
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Number of Hospital Visits
Zeitfenster: 6 months
|
6 months
|
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Number of Hospital Visits
Zeitfenster: 12 months
|
12 months
|
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Percentage of baseline health-harming legal needs that were resolved
Zeitfenster: baseline
|
baseline
|
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Percentage of baseline health-harming legal needs that were resolved
Zeitfenster: 3 months
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3 months
|
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Percentage of baseline health-harming legal needs that were resolved
Zeitfenster: 6 months
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6 months
|
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Percentage of baseline health-harming legal needs that were resolved
Zeitfenster: 12 months
|
12 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Winston Liaw, MD, MPH, The University of Texas Health Science Center, Houston
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
14. Februar 2019
Primärer Abschluss (Tatsächlich)
11. September 2020
Studienabschluss (Tatsächlich)
11. September 2020
Studienanmeldedaten
Zuerst eingereicht
11. Januar 2019
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
11. Januar 2019
Zuerst gepostet (Tatsächlich)
15. Januar 2019
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
6. November 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
4. November 2020
Zuletzt verifiziert
1. November 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- HSC-MS-18-1037
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Nein
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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