Treatment Adherence and ComplianceHemodialysisNCT06742827
Educational Intervention and Adherence
A study testing educational intervention based on information and communication technologies. in people with Treatment Adherence and Compliance and Effectiveness, run by Universidad de Antioquia at 1 site in Colombia.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Treatment Adherence and Compliance, Effectiveness, Renal Dialysis
- What is being tested?
- educational intervention based on information and communication technologies.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteColombia
- Study dates
- 15 Nov 2024to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Signs or symptoms as a result of target organ damage
- Cognitive, hearing or visual impairments that prevent them from adequately receiving the educational intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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.
- 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.
- Being tested
- educational intervention based on information and communication technologies.
- Keywords
- Treatment Adherence and Compliance, Effectiveness, Renal Dialysis, Nursing
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational intervention based on information and communication technologies.Other
Also called ICT educational intervention
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group: participants will receive an educational intervention on hemodialysis adherence) Receives: Other: educational intervention based on information and communication technologies. |
| Control | No intervention | Control group:participants will receive conventional care provided by health professionals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of ESRD-AQ
Score of the End-Stage Renal Disease-Adherence Questionnaire (ESRD-AQ)
Measured: PRE (baseline, pre-intervention) and POST (immediately after the intervention)
Score of SOC
Score of the scale Sense of Coherence (SOC)
Measured: PRE (baseline, pre-intervention) and POST (immediately after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start15 Nov 2024
- Primary completion15 Feb 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Treatment Adherence and ComplianceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742827
- Sponsor's protocol ID
- CEI-FE 2024-136
- Acronym
- Hemodialysis
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35703232Newman 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.
PubMed 20531258Goode CJ. Evaluation of research-based nursing practice. Nurs Clin North Am. 1995 Sep;30(3):421-8.
PubMed 7567568Mittelmark 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.
PubMed 23797938Arad 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.
PubMed 33827478Banning 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.
PubMed 19394018
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Educational Intervention by Nurses Supported by ICTs to Improve Therapeutic Adherence in People Undergoing Hemodialysis Treatment
- ClinicalTrials.gov ID
- NCT06742827
- Acronym / sponsor ID
- Hemodialysis / CEI-FE 2024-136
- Keywords
- Treatment Adherence and Compliance, Effectiveness, Renal Dialysis, Nursing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: educational intervention based on information and communication technologies.Intervention group: participants will receive an educational intervention on hemodialysis adherence) |
| Control | No intervention | –Control group:participants will receive conventional care provided by health professionals |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Signs or symptoms as a result of target organ damage
- Cognitive, hearing or visual impairments that prevent them from adequately receiving the educational intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational intervention based on information and communication technologies.Also: ICT educational interventionwill 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 | Intervention |
Primary outcome
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)
Score of SOC
Time frame: PRE (baseline, pre-intervention) and POST (immediately after the intervention)
Score of the scale Sense of Coherence (SOC)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Background: PubMed 35703232Park 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.
- Background: PubMed 20531258Newman 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.
- Background: PubMed 7567568Goode CJ. Evaluation of research-based nursing practice. Nurs Clin North Am. 1995 Sep;30(3):421-8.
- Background: PubMed 23797938Mittelmark 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.
- Background: PubMed 33827478Arad 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.
- Background: PubMed 19394018Banning 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention based on information and communication technologies. in people with Treatment Adherence and Compliance and Effectiveness, run by Universidad de Antioquia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of ESRD-AQ (time frame: PRE (baseline, pre-intervention) and POST (immediately after the intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06742827, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024; AzTrials last refreshed its copy on 27 Oct 2026.