NCT04738669

Brief Summary

The Study is a feasibility randomized controlled trial aiming to assess the feasibility of mHealth (voice call and SMS) and teach-back interventions on reducing the 30 days readmission rate in the patients enrolled in the Sehat Sahulat Programme (Prime Minister National Health Programme(PMNHP)). The prime objective of this study was to generate a proof of concept for the conduct of a definitive trial for the reduction in readmissions in PMNHP. A feasibility randomized controlled trial study consisted of three arms i.e intervention 1 (telephonic contact and text messages), intervention 2 (teach-back method) and control is planned in program beneficiaries of Islamabad, Pakistan. The trial is being carried out in the three hospitals of Islamabad and patients are being recruited as per the inclusion and exclusion criteria.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

January 21, 2021

Last Update Submit

February 9, 2021

Conditions

ReadmissionmHealthTeach-Back Communication

Keywords

ReadmissionMobile healthmHealthTeach-Back Communication

Outcome Measures

Primary Outcomes (4)

  • Readmission within 7 days post discharge

    7 Days after discharge, participants were assessed for readmission.

    7 days post discharge.

  • Readmission within 14 days post discharge

    14 Days after discharge, participants were assessed for readmission.

    14 days post discharge.

  • Readmission within 21 days post discharge

    21 Days after discharge, participants were assessed for readmission

    21 Days post discharge

  • Readmission within 30 days post discharge

    30 Days after discharge, participants were assessed for readmission

    30 Days post discharge

Study Arms (3)

Control Arm

NO INTERVENTION

No intervention is being conducted in this arm. Routine care is being given to these patients. The patients will be followed up for any readmissions during the intervention period.

mHealth Arm

EXPERIMENTAL

This arm will receive first receive weekly telephone call followed by the SMS in Urdu regarding medication adherence according to the discharge instructions. The calls and SMS will be sent on 7, 14, 21 and 30th day post-index discharge. The patients will be followed up for any readmissions during the intervention period.

Other: mHealth

Teach back arm

EXPERIMENTAL

The trained doctors thoroughly explained the discharge instructions, medication schedule and any other self-care instructions to these participants and asked them to repeat what they have understood from the doctor verbal counselling. If the instructions were not clearly comprehended by the patients, then the same would be repeated by the consultant doctor. The patients will be followed up for any readmissions during the intervention period.

Behavioral: Teach-back

Interventions

mHealthOTHER

The mHealth intervention includes telephonic call and SMS.

mHealth Arm
Teach-backBEHAVIORAL

While the teach-back includes counselling session related to discharge instruction including medication adherence.

Teach back arm

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients \> 30 years of age
  • Incident adult cases with index admission in PMNHP
  • Ischemic Heart disease, Myocardial Infarction, Hypertension, Diabetes Mellitus, Bronchial Asthma
  • Patients with a valid mobile number
  • Able to read the SMS in Urdu

You may not qualify if:

  • Serious mental illness such as schizophrenia,
  • Are unable to use a telephone
  • Are cognitively impaired during hospitalization as diagnosed by the consultant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alkhidmat AlRazi Hospital

Islamabad, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Teach-Back Communication

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

CommunicationBehavior

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Assad Hafeez, PhD

    Health Services Academy, Pakistan

    STUDY DIRECTOR

Central Study Contacts

Syed Fawad Mashhadi, MPH, MPhil

CONTACT

+923218543782phd15fawad@hsa.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Fellow

Study Record Dates

First Submitted

January 21, 2021

First Posted

February 4, 2021

Study Start

March 1, 2020

Primary Completion

March 1, 2021

Study Completion

June 1, 2021

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)