- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Meheret Amare, Doctor of Medicine
- Numero di telefono: +251919373034
- Email: meheretyeshitila3@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
|
|
Comparatore attivo: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Rate of identification of patients with palliative care needs.
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Qualitative assessment of implementation barriers and enablers.
Lasso di tempo: 6 weeks
|
Evaluation of implementation determinants (barriers and facilitators) through focus group discussions with health extension workers
|
6 weeks
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- MPH/039/18
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cure palliative
-
National Taiwan University HospitalNon ancora reclutamento
-
VA Office of Research and DevelopmentNon ancora reclutamentoCare di basso valoreStati Uniti
-
Research Unit Of General Practice, CopenhagenUniversity of Copenhagen; Region Capital Denmark; The Copenhagen General Practice... e altri collaboratoriCompletato
-
University Health Network, TorontoNon ancora reclutamento
-
National Taiwan University HospitalCompletatoEcografia Point-of-careTaiwan
-
Asociacion Española Primera en SaludIntensive Care Unit Pasteur HospitalCompletatoEcografia Point of CareUruguay
-
Aga Khan UniversityThe Hospital for Sick Children; Grand Challenges CanadaSconosciuto
-
University of ArizonaNon ancora reclutamentoGruppo 1: Carrier Care (CC) seguito da Skin-to-Skin Care (SSC) seguito dalla scelta della famiglia | Gruppo 2: cura della pelle a pelle (SSC) seguito da Carrier Care (CC) seguito dalla scelta della famiglia
-
Indiana UniversityReclutamentoEcografia Point of Care (POCUS)Stati Uniti
-
Medical University of WarsawReclutamentoEcografia Point of Care (POCUS) | Hemodynamic Assessment | Bedside UltrasonographyPolonia
Prove cliniche su DINKNESH App
-
The University of Hong KongNon ancora reclutamentoSalute digitale | Dolore al ginocchio/artrosiHong Kong
-
Institute for Human Development and Potential (IHDP)...Attivo, non reclutanteDiabete di tipo 2 | Diabete gestazionale | Comportamenti di stile di vita saniSingapore
-
London School of Hygiene and Tropical MedicineCompletatoNutrizione | Sostenibilità | Tecnologia sanitaria mobile (mHealth)Regno Unito
-
Emory UniversityNational Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)Completato
-
University of ConnecticutYale University; National Institutes of Health (NIH); University of MalayaCompletatoProgramma di prevenzione dell'HIVMalaysia
-
University of Nevada, Las VegasSanvelloCompletatoDepressione, AnsiaStati Uniti
-
Annette MönninghoffETH Zurich; Helsana Zusatzversicherungen AGCompletato
-
University of Sao PauloGrand Challenges Canada; Fundaçao Maria Cecilia Souto VidigalRitiratoDepressione maternaBrasile
-
Sutter HealthIscrizione su invito
-
Northwestern UniversityNational Institute of Mental Health (NIMH); Rush UniversityCompletatoDepressione | AnsiaStati Uniti