Post-HSCT Medication Adherence mHealth App

NCT ID: NCT04976933

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-15

Study Completion Date

2023-01-31

Brief Summary

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Through a mixed methods, quasi-experimental design, the study will first focus on developing a mobile health (mHealth) adherence application and evaluating usability and acceptability of the app among caregivers of children in the acute phase post-HSCT. The purpose of this project is to explore the feasibility and acceptability of a mHealth application through user testing and thematic content analysis.

Detailed Description

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Conditions

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Stem Cell Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Primary Caregivers

Primary caregivers of children receiving Tacrolimus or cyclosporine immunosuppression for an allogeneic transplant will be introduced to the mHealth adherence app and allowed the opportunity to interact with the app alongside research staff. Following this session primary caregivers are asked to use the app at home until Day 100 or weaning of immunosuppressant, whichever is first.

mHealth adherence app

Intervention Type BEHAVIORAL

The mHealth app is designed to remind caregivers to give medication in the outpatient setting, track adherence, and capture real time barriers to adherence if medication is missed.

Interventions

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mHealth adherence app

The mHealth app is designed to remind caregivers to give medication in the outpatient setting, track adherence, and capture real time barriers to adherence if medication is missed.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* English-speaking
* \>18 years of age

Exclusion Criteria

* Caregivers with developmental delays or conditions that make processing and responding to verbal questions challenging/frustrating either online or in a group forum
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Micah Skeens

OTHER

Sponsor Role lead

Responsible Party

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Micah Skeens

Nurse Scientist/Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Micah Skeens, PhD APRN CPNP

Role: PRINCIPAL_INVESTIGATOR

Abigail Wexner Research Institute at Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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Skeens M, Sezgin E, Stevens J, Landier W, Pai A, Gerhardt C. An mHealth App to Promote Adherence to Immunosuppressant Medication and Track Symptoms in Children After Hematopoietic Stem Cell Transplant: Protocol for a Mixed Methods Usability Study. JMIR Res Protoc. 2022 Jul 21;11(7):e39098. doi: 10.2196/39098.

Reference Type DERIVED
PMID: 35862184 (View on PubMed)

Other Identifiers

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K99NR019115-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00000910

Identifier Type: -

Identifier Source: org_study_id

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