- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Meheret Amare, Doctor of Medicine
- Phone Number: +251919373034
- Email: meheretyeshitila3@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of identification of patients with palliative care needs.
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative assessment of implementation barriers and enablers.
Time Frame: 6 weeks
|
Evaluation of implementation determinants (barriers and facilitators) through focus group discussions with health extension workers
|
6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MPH/039/18
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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