NCT07574281

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
Last Updated

May 7, 2026

Status Verified

February 1, 2026

Enrollment Period

1 month

First QC Date

March 20, 2026

Last Update Submit

May 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of identification of patients with palliative care needs.

    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

Secondary Outcomes (1)

  • Qualitative assessment of implementation barriers and enablers.

    6 weeks

Study Arms (2)

DINKNESH App

EXPERIMENTAL

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

Other: DINKNESH App

Paper based Tool

ACTIVE COMPARATOR

Family Health Teams in these clusters will provide home-based chronic care services following standard paper based without the use of the digital application.

Other: Paper based tool

Interventions

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

DINKNESH App

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.

Paper based Tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Meheret Amare, Doctor of Medicine

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 20, 2026

First Posted

May 7, 2026

Study Start

April 1, 2026

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

May 7, 2026

Record last verified: 2026-02