Educational Intervention and Adherence (Hemodialysis)

December 18, 2024 updated by: Universidad de Antioquia

Effectiveness of an Educational Intervention by Nurses Supported by ICTs to Improve Therapeutic Adherence in People Undergoing Hemodialysis Treatment

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)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is quantitative in approach and will be conducted in three phases: Phase I: development of the intervention, Phase II: validation by expert consensus for the content of the nursing intervention. Phase III a randomized clinical trial.

I. Development of the intervention During this phase knowledge gained from theoretical and empirical approaches will play a key role in creating an effective intervention aimed at improving treatment adherence in hemodialysis patients. An intervention guided by salutogenic theory and mediated by ICTs will be used. Each of these approaches provides a unique and valuable perspective that enriches our understanding of the problem, thus facilitating informed decision making during the planning and implementation phase of interventions.

As for the theoretical-empirical understanding of the problem, which will perform the combination of theoretical and empirical approach in order to make the clear identification of the problem, requiring resolution of its determinants, severity, consequences, as well as, evidencing the support of the intervention through the incorporation of theories that guide the development of the intervention while seeking to establish the relationship between the characteristics of the problem and empirical components.

Description of the Nursing Educational Intervention:

Regarding the theoretical approach, Antonovsky's salutogenic theory is incorporated, which makes it possible to understand the problem. This theory, which is broad and comprehensive, adopts a salutogenic perspective by viewing people as biopsychosocial beings who make choices in their lives. It allows individuals to identify the psychosocial resources that contribute to maintaining their health and well-being. In this sense, Antonovsky introduces the concept of "sense of coherence", which comprises the elements of comprehensibility (knowledge), manageability (behavior) and meaningfulness (motivation).

From the empirical approach, the literature review has revealed that therapeutic adherence is a complex phenomenon, influenced by a variety of factors and has been the subject of study in various disciplines, including nursing. To address this issue effectively, it is necessary to implement educational interventions that promote health and well-being in people undergoing hemodialysis.

Content of the Intervention:

Regarding delivery strategies, it will be carried out through a mobile application, which will be installed on each person's device, likewise short text messages will be sent and counseling will be done with 24/7 counseling availability. The contents of the application will be educational and will be developed within the framework of the following components

II. RANDOMIZED CLINICAL TRIAL:

Type of study. Intervention study of the parallel type randomized controlled clinical trial type. For the reporting of the results, the extent of the Consort Statement for randomized clinical trials of non-pharmacological interventions will be taken into account. The randomized controlled trial is considered to be the most rigorous and robust research method for determining whether a cause-effect relationship exists between an intervention and an outcome.

Study Setting. The study will be carried out in a renal unit in the city of Barranquilla.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 80001
        • Barranquilla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Intervention group: participants will receive an educational intervention on hemodialysis adherence)
Other: educational intervention based on information and communication technologies.
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).
Other Names:
  • ICT educational intervention
No Intervention: Control
Control group:participants will receive conventional care provided by health professionals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of ESRD-AQ
Time Frame: PRE (baseline, pre-intervention) and POST (immediately after the intervention)
Score of the End-Stage Renal Disease-Adherence Questionnaire (ESRD-AQ)
PRE (baseline, pre-intervention) and POST (immediately after the intervention)
Score of SOC
Time Frame: PRE (baseline, pre-intervention) and POST (immediately after the intervention)
Score of the scale Sense of Coherence (SOC)
PRE (baseline, pre-intervention) and POST (immediately after the intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Antioquia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2024

Primary Completion (Estimated)

February 15, 2025

Study Completion (Estimated)

August 15, 2025

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

December 18, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 18, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CEI-FE 2024-136

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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