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OpenTrials
Active, Not Recruiting

NCT Number: NCT06742827

Educational Intervention and Adherence

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barranquilla

Barranquilla, Atlántico, 80001, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: ICT educational intervention

Primary outcomes

  1. 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)

  2. Score of SOC

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

    Score of the scale Sense of Coherence (SOC)

Sponsors and collaborators

Lead sponsor

Universidad de Antioquia

Other

Registry information

Official study title

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

Acronym: Hemodialysis

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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