A Pilot Study to Improve Diabetes Management Through Family-Based Health Care Navigation (HOOKELE)
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
The purpose of this small R01 is to test the feasibility and preliminary efficacy of a family-based DSMES and social care navigation intervention to improve diabetes-related outcomes among NHPI patients with poorly managed diabetes and social needs. KP Hawaii NHPI patients (N = 80) age ≥ 18, recent A1C >8%, and who report >1 social needs will be recruited and randomized to one of two study arms: 1) family-based group centered DSMES and social care navigation intervention; or 2) enhanced usual care. In the family-based intervention, participants and their family members will receive the 6-week NHPI culturally adapted DSMES program that will be delivered by a NHPI pharmacist from the Mauliola Pharmacy. In collaboration with our partners, Hui No Ke Ola Pono, a community-based organization that employs CHWs, enrolled participants and their family members will be assigned a NHPI CHW who will provide navigation support to social services and community-based resources to address social needs for 6 months. Participants in the enhanced usual care arm will receive standard diabetes clinical care and be provided with a tailored community-based resource list. Feasibility will be determined using mixed methods and based on recruitment, retention, attendance, social need resolution, and several implementation outcomes. We will also examine intervention preliminary effects on diabetes distress, self-management, self-efficacy/empowerment, A1C, and healthcare utilization at 6 months. We propose the following aims:
Aim 1. Determine feasibility of the family-based group centered DSMES and social care navigation intervention based on: a) recruitment and retention rates; b) session attendance; c) number of participants with social need(s) met, not met, or pending at 6 months; d) acceptability; e) practicality; f) fidelity; and g) cultural appropriateness.
Aim 2. Explore preliminary efficacy by comparing the two study arms on the following outcomes at 6-months post-randomization: a) diabetes distress; b) diabetes self-management; c) diabetes self-efficacy; d) mean change in A1C; e) proportion of participants with a clinic-based A1C test; and f) proportion of patients who attended a scheduled follow-up primary care appointment.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Maile Taualii, PhD, MPH
- Telefonnummer: 808-462-1437
- E-Mail: maile.m.taualii@kp.org
Studieren Sie die Kontaktsicherung
- Name: Jonathan Lai
- Telefonnummer: 808- 476-1747
- E-Mail: jonathan.ws.lai@kp.org
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- age 18 or older;
- identify as Native Hawaiian or Pacific Islander;
- diagnosed with type 2 diabetes;
- most recent A1C ≥ 8%;
- reports ≥ 1 social need;
- receive care at KPHI, and
- have an adult family member who will commit to attending classes with the participant.
Exclusion Criteria: Patients who are not able to provide informed consent due to cognitive impairment
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Family-based group-centered DSMES plus social care navigation intervention
In the family-based group-centered intervention, participants and their family member (who may be food preparers or meal planners such as spouses, parents, or adult children) will participate in an existing 6-week, NHPI culturally adapted DSMES program offered by a NHPI community partner.
Each participant and family unit will be assigned a NHPI CHW who will provide navigation support to social services and community-based resources to address social needs for 6 months.
|
In the family-based group-centered intervention, participants and their family member (who may be food preparers or meal planners such as spouses, parents, or adult children) will participate in an existing 6-week, NHPI culturally adapted DSMES program offered by a NHPI community partner.
Each participant and family unit will be assigned a NHPI CHW who will provide navigation support to social services and community-based resources to address social needs for 6 months.
|
|
Aktiver Komparator: Enhanced routine care
Participants in the enhanced routine care arm will receive the standard diabetes clinical care at KP Hawaii and be provided with a tailored community-based resource list.
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Participants in the enhanced routine care arm will receive the standard diabetes clinical care at KP Hawaii and be provided with a tailored community-based resource list.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Feasibility of the family-based DSMES and social care intervention
Zeitfenster: 6-months follow-up
|
Fidelity
|
6-months follow-up
|
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Feasibility of the family-based DSMES and social care intervention
Zeitfenster: 6-months follow-up
|
Fidelity
|
6-months follow-up
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Maile Taualii, PhD, MPH, Kaiser Permanente
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- R01DK142020 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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