- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07574281
Effectiveness and Implementation of the DINKNESH Digital Palliative Care Tool in Ethiopia
Effectiveness and Implementation Determinants of the DINKNESH App Compared to Paper-Based Assessment Tools for Palliative Care: A Mixed-Methods Cluster Randomized Trial in Addis Ababa, Ethiopia
The goal of this clinical trial is to learn if a digital health app called DINKNESH is effective for palliative care identification compared to traditional paper-based assessment tools. It will also look at the factors that help or hinder the use of this app in primary care settings.
The main questions it aims to answer are:
Does the DINKNESH app improve palliative care assessments compared to paper forms?
What are the main barriers and facilitators for Health Extension Workers when using the app in their daily work?
We will compare the DINKNESH app to standard paper-based tools to see if digital tools improve clinical assessment and implementation.
Participants will:
Be assessed for palliative care needs using either the DINKNESH mobile app or standard paper forms.
Receive routine follow-up care as determined by their health provider.
(For health workers): Participate in interviews or surveys to discuss their experience using the assigned assessment tool.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Meheret Amare, Doctor of Medicine
- Telefonnummer: +251919373034
- E-Mail: meheretyeshitila3@gmail.com
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria
For patients(Quantitative Part):
- Adults aged 18 years or older
- Currently diagnosed with one or more chronic conditions and receiving home-based follow-up care from a participating Family Health Team within the catchment area of a selected study cluster
- Willing to provide verbal informed consent, or has a primary caregiver willing to provide proxy consent
For healthcare workers:
- Staff members of the Family Health Team at the selected clusters
- Involved in delivering or supervising palliative care services during the study period
- For the qualitative part: Participated in the DINKNESH App implementation process and is willing to participate in a Focus Group Discussion (FGD)
Exclusion Criteria
For patients
- Patients whose clinical condition prevents both self-participation and proxy participation in the assessment process
- Patients already formally identified and referred for palliative care prior to the study period
For healthcare workers:
- Staff members planning to be absent for more than 1 day during the six-week active study period
- Healthworkers not present during the training session
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: DINKNESH App
Healthcare workers (Family Health Teams) in these clusters will utilize the DINKNESH mobile application during routine home-based visits to systematically identify and assess patients requiring palliative care.
The app integrates validated tools (SPICT, ECOG, IPOS) and provides clinical decision support for symptom management, counseling, and referral protocols
|
A mobile-based digital health application designed to support Family Health Teams in the systematic identification and assessment of patients with palliative care needs.
The application digitizes validated clinical tools, including the Supportive and Palliative Care Indicators Tool (SPICT), the Eastern Cooperative Oncology Group (ECOG) performance status, and the Integrated Palliative care Outcome Scale (IPOS) along with reference materials
|
|
Aktiver Komparator: Paper based Tool
Family Health Teams in these clusters will provide home-based chronic care services following standard paper based without the use of the digital application.
|
A paper-based clinical assessment protocol designed to support Family Health Teams in the systematic identification and assessment of patients with palliative care needs.
It incorporates the same validated clinical tools used in the intervention arm, including the Supportive and Palliative Care Indicators Tool (SPICT), the Eastern Cooperative Oncology Group (ECOG) performance status, and the Integrated Palliative care Outcome Scale (IPOS), administered manually during routine home visits without the use of a digital application and reference material.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Rate of identification of patients with palliative care needs.
Zeitfenster: 6 weeks
|
The primary outcome is the rate of palliative care identifications, calculated as the number of individuals identified as requiring palliative care divided by the total number of chronic patient visit conducted by the Family Health Teams during the study period.
|
6 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Qualitative assessment of implementation barriers and enablers.
Zeitfenster: 6 weeks
|
Evaluation of implementation determinants (barriers and facilitators) through focus group discussions with health extension workers
|
6 weeks
|
Mitarbeiter und Ermittler
Sponsor
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
Andere Studien-ID-Nummern
- MPH/039/18
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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