Clinical trial NCT06742827: Educational Intervention and Adherence
Official title: Effectiveness of an Educational Intervention by Nurses Supported by ICTs to Improve Therapeutic Adherence in People Undergoing Hemodialysis Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Treatment Adherence and Compliance
Effectiveness
Renal Dialysis
Nurse's Role
Keywords: Treatment Adherence and Compliance
Effectiveness
Renal Dialysis
Nursing
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Score of ESRD-AQ
timeFrame: PRE (baseline, pre-intervention) and POST (immediately after the intervention)
measure: Score of SOC
timeFrame: PRE (baseline, pre-intervention) and POST (immediately after the intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: Barranquilla
state: Atlantico
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.