NCT06742827

Brief Summary

quasi-experimental, parallel study, with the objective of evaluating the effectiveness of an educational nursing intervention supported by ICTs, for the improvement of therapeutic adherence in people undergoing hemodialysis treatment in a renal unit in Barranquilla (Colombia)

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

November 15, 2024

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 19, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

December 4, 2024

Last Update Submit

December 18, 2024

Conditions

Treatment Adherence and ComplianceEffectivenessRenal DialysisNurse's Role

Keywords

Treatment Adherence and ComplianceEffectivenessRenal DialysisNursing

Outcome Measures

Primary Outcomes (2)

  • Score of ESRD-AQ

    Score of the End-Stage Renal Disease-Adherence Questionnaire (ESRD-AQ)

    PRE (baseline, pre-intervention) and POST (immediately after the intervention)

  • Score of SOC

    Score of the scale Sense of Coherence (SOC)

    PRE (baseline, pre-intervention) and POST (immediately after the intervention)

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention group: participants will receive an educational intervention on hemodialysis adherence)

Other: educational intervention based on information and communication technologies.

Control

NO INTERVENTION

Control group:participants will receive conventional care provided by health professionals

Interventions

educational intervention based on information and communication technologies.OTHER

will be carried out through a mobile application, which will be installed on each person's device, as well as short text messages will be sent and counseling will be available 24/7. The contents of the application will be educational and will be elaborated framed in the following components: understanding of the disease and the consequences of not adhering (comprehensibility) to the treatment, maintaining a balance between the psychosocial resources that the patient has and the demands that the disease places on them (manageability), and the involvement of the person in decision making and the sense of continuing to adhere to hemodialysis treatment (meaningfulness).

Also known as: ICT educational intervention
Intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 60 years old
  • In hemodialysis treatment for at least 3 months for three or four hours, with a frequency of three times a week in a renal
  • Must live in Barranquilla
  • Must be independent in self-care activities such as being able to walk and eat without assistance
  • Must have access to an Android or Apple cell phone which is in daily use.

You may not qualify if:

  • Signs or symptoms as a result of target organ damage
  • Cognitive, hearing or visual impairments that prevent them from adequately receiving the educational intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barranquilla

Barranquilla, Atlántico, 80001, Colombia

Location

Related Publications (6)

  • Park J, Park J. Identifying the Knowledge Structure and Trends of Nursing Informatics: A Text Network Analysis. Comput Inform Nurs. 2023 Jan 1;41(1):8-17. doi: 10.1097/CIN.0000000000000919.

    PMID: 35703232BACKGROUND

  • Newman MA, Smith MC, Pharris MD, Jones D. The focus of the discipline revisited. ANS Adv Nurs Sci. 2008 Jan-Mar;31(1):E16-27. doi: 10.1097/01.ANS.0000311533.65941.f1. No abstract available.

    PMID: 20531258BACKGROUND

  • Goode CJ. Evaluation of research-based nursing practice. Nurs Clin North Am. 1995 Sep;30(3):421-8.

    PMID: 7567568BACKGROUND

  • Mittelmark MB, Bull T. The salutogenic model of health in health promotion research. Glob Health Promot. 2013 Jun;20(2):30-8. doi: 10.1177/1757975913486684.

    PMID: 23797938BACKGROUND

  • Arad M, Goli R, Parizad N, Vahabzadeh D, Baghaei R. Do the patient education program and nurse-led telephone follow-up improve treatment adherence in hemodialysis patients? A randomized controlled trial. BMC Nephrol. 2021 Apr 7;22(1):119. doi: 10.1186/s12882-021-02319-9.

    PMID: 33827478BACKGROUND

  • Banning M. A review of interventions used to improve adherence to medication in older people. Int J Nurs Stud. 2009 Nov;46(11):1505-15. doi: 10.1016/j.ijnurstu.2009.03.011. Epub 2009 Apr 24.

    PMID: 19394018BACKGROUND

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2024

First Posted

December 19, 2024

Study Start

November 15, 2024

Primary Completion

February 15, 2025

Study Completion

August 15, 2025

Last Updated

December 19, 2024

Record last verified: 2024-12

Locations

CO(1)