Medication NonadherenceNCT03324386
The Use of Educational Technology in Improving Adherence Therapy
A study testing Experimental: Individual Orientation, Experimental: VLE for Distance Learning and Experimental: E-blended Lerarning in people with Medication Nonadherence and Hypertension, Resistant to Conventional Therapy, run by University of Sao Paulo General Hospital.
Trial summary
Few studies show the benefits of educational technologies a support for the control of chronic diseases. The approach known as 'embracement' adopts relational strategies or soft technologies which promote bonding and may impact therapy adherence and quality of life in hypertensive patients.Objectives:To assess the… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Medication Nonadherence, Hypertension, Resistant to Conventional Therapy
- What is being tested?
- Experimental: Individual Orientation, Experimental: VLE for Distance Learning and Experimental: E-blended Lerarning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- 18 Dec 2013to 17 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have the medical diagnosis of arterial hypertension,
- Have blood pressure levels equal or above 140 mmHg for systolic blood pressure (SBP), and equal or above 90 mmHg for diastolic blood pressure (DBP),
- Must be able to swallow tablets and under drug treatment with antihypertensives,
- Have digital accessibility through smart phones, tablets or notebooks and PCs.
Who cannot join
- Patients with important cognitive impairment will be considered excluded, that is, with poor understanding of simple questions,
- Clinical diagnosis of Alzheimer's disease, or chorea diseases that lead to cognitive impairment such as senile dementia,
- Diagnosis of insulin dependent diabetes. -
About this study
Official title: HYPERTENSIVE PATIENT ADHERENCE TO TREATMENT: THE USE OF THERAPEUTIC COMMUNICATION ASSOCIATED WITH TECHNOLOGY EDUCATIONAL IN HEALTH PROMOTION"
Few studies show the benefits of educational technologies a support for the control of chronic diseases. The approach known as 'embracement' adopts relational strategies or soft technologies which promote bonding and may impact therapy adherence and quality of life in hypertensive patients.Objectives:To assess the impact of the embracement approach on therapy adherence, quality of life, and the white coat effect in hypertensive outpatients followed in a specialized clinic. This approach may be associated or not with the use of educational technology in a virtual learning environment(VLE) for distance learning (DL) and with use the educational technology in Blended E-learning (E-BLENDED)
Read the detailed description
Hypertension (HBP) is an important risk factor for cardiovascular disease and has become a common public health problem world wide due to increased longevity. The challenge for next decades is to improve the adherence of patients with chronic degenerative diseases. It is detected that hypertension has been considered a risk factor for determining the incidence of cardiovascular diseases, which directs it to the high cost of treatment in Brazilian public health, therefore the prevention of impairment to health is a priority. Many patients with hypertension do not make the required behavioral changes in your lifestyle, do not forget to take medications or taking medication to fulfil the effective control of the disease. The present study aims to assess the impact of a health promotion program using the Therapeutic Communication and Educational Technology associated of the telemedicine (E-Care of Hypertension) in the performance improvement of patient adherence to treatment. This study aims to evaluation the impact of health promotion program on therapeutic compliance in hypertensive patients, of difficult control of blood pressure levels, with individual guidance through nursing consultation every 20 days, using the approach of "Therapeutic Communication" associated "Educational Technology" for a period of 120 days. For this study will be conducted with 60 patients randomly divided into four groups, according to the care of new cases registered in Ambulatory Hypertension Unit of Heart Institute at Medical School of São Paulo University. The sample will be selected for convenience in accordance with the established day of the week depending on availability of researchers and patients' consent. This approach may be associated or not with the use of educational technology in a virtual learning environment (VLE) for distance learning (DL).This was a prospective randomized clinical study conducted with the following 4 groups of hypertensive patients: This was a prospective randomized clinical study conducted with the following 4 groups of hypertensive patients: Embracement: Group receiving individual orientation required by an embracement strategy characterized by 7 nursing visits at 20-day intervals, for 4 months; Group VLE using a technological education strategy (E-Care of Hypertension) for distance learning (DL) and making 7 nursing visits at 20-day intervals, for 4 months; Control Group that performed 1 nursing visit at baseline and 1 after 120 days.). Group E-blended learning using a technological education strategy (E-Care of Hypertension) which is evaluating the influence of the use of educational technology associated with face-to-face consultation with the health professional (Blended E-learning) and making 7 nursing visits at 20-day intervals, for 4 months. At baseline and after 120 days, the following tools were applied: The Spielberger State-Trait Anxiety Inventory (STAI), the Morisky test, WHOQOL, and ambulatory blood pressure monitoring (ABPM). The VLE group had remote access to the "E-Care of Hypertension" site (6 specific educational modules).The E-BLENDED Group had acess to "E-Care of Hypertension" site (6 specific educational modules) with the presence of the nurse.
- Being tested
- Experimental: Individual Orientation, Experimental: VLE for Distance Learning, Experimental: E-blended Lerarning, Conventional Therapy - Control Group
- Keywords
- Hypertension, Tecnology, Nursing, Education
- Medical subject headings
- Medication Adherence, Hypertension Resistant to Conventional Therapy, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Individual OrientationBehavioural
This approach may be individual orientation with by an embracement strategy (relational strategies) may be making 7 nursing visits at 20-day intervals, for 4 month.
Experimental: VLE for Distance LearningBehavioural
Experimental: This approach may be associated with the use of educational technology (E-Care of Hypertension) in a virtual learning environment(VLE) for distance learning (DL) consultation with the health professional and making 7 nursing visits at 20-day intervals, for 4 months
Experimental: E-blended LerarningBehavioural
This approach may be associated with the use of educational technology (E-Care of Hypertension) in the blended e-learning mode associated with face-to-face with the health professional and making 7 nursing visits at 20-day intervals, for 4 months
Conventional Therapy - Control GroupOther
This approach may be individual orientation with conventional therapy may be making 2 nursing visits at baseline and 1 after 120 days,
| Study group | Role | What they receive |
|---|---|---|
| Individual Orientation | Experimental | This was a prospective randomized clinical study conducted with the following 4 groups of hypertensive patients: Experimental: individual orientation: receiving individual orientation required by an embracement strategy characterized by 7 nursing visits at 20-day intervals, for 4 months);The ntervention is composed by relational strategies characterized by interpersonal relationships Receives: Behavioral: Experimental: Individual Orientation; Behavioral: Experimental: VLE for Distance Learning |
| VLE for Distance Learning | Experimental | This was a prospective randomized clinical study conducted with the following 4 groups of hypertensive patients:Experimental: a technological education strategy for distance learning (DL), using a technological education strategy (E-Care of Hypertension) for Distance Learning (DL) characterized by 7 nursing visits at 20-day intervals, for 4 months). The intervention is composed by the use of equipment-oriented techniques or audio-visual aids in educational environments remotely accessed for health education specifically for hypertensive patients Receives: Behavioral: Experimental: Individual Orientation; Behavioral: Experimental: E-blended Lerarning |
| E-blended Learning | Experimental | This was a prospective randomized clinical study with the patient received experimental intervention: a technological education strategy with E-blended Learning modality with E-Care of Hypertension, associated with face-to-face consultation with the health professional and making 7 nursing visits at 20-day intervals, for 4 months. The intervention is composed by the use of equipment-oriented techniques or audio-visual aids in presential educational environments intended for health education specifically for hypertensive patients Receives: Behavioral: Experimental: Individual Orientation; Behavioral: Experimental: VLE for Distance Learning; Behavioral: Experimental: E-blended Lerarning; Other: Conventional Therapy - Control Group |
| No intervention | No intervention | No type of intervention was performed making 2 nursing visits at baseline and 1 after 120 days (No intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure blood arterial pressure
At the first nurse interview (day 0: randomization), a questionnaire was used to obtain information related to general data, habits, history of disease, other risk factors for cardiovascular disease, and prescribed medications. This questionnaire was used only to characterize the adherence behavior and the risk factors at the beginning the study, but was not used to evaluate modifications of behavior during the study. Body weight and height were measured. Three consecutive measurements of BP were taken after the patient had rested for 5 min in the supine position.
Measured: 4 months
Ambulatory Blood Pressure monitoring
Ambulatory BP monitoring was recorded at day ) in randomization and 120 days of follow-up for 24 h with a noninvasive ABPM (Space Labs 90207 monitor; Space Labs, Redmond, WA) with an appropriate-sized cuff. The monitor was placed on the nondominant arm and was set to take BP readings every 10 min during the day and every 20 min at nigh
Measured: 4 months
Pill count
count of the compliments dispensed by the pharmacy and count of the empty blisters delivered in the consultation
Measured: up to 4 months
Secondary outcomes (2)
The brief version of the World Health Organization quality of life (WHOQOL-BREF)
Questinaire
Measured: 4 months
The Duke University Religion Index (DUREL) for a brief measure of religiosity that can be included between religion and health outcomes.
the isntrument
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start18 Dec 2013
- Primary completion25 Apr 2015
- Study completion17 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication NonadherenceStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- VLE Group use the technology in a virtual learning environment(VLE) for distance learning (DL), HYBRID Group use the educational technology in the E-blended mode leraning, A Group he use of embracement strategy (relational strategies).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Luiz Aparecido Bortolotto, Chao Lung Wen, Margarida Vieira, Miriam Harume Tsunemi, Isabela Ribeiro Braga Fistarol, Jefferson Carlos de Oliveira, Dante Marcelo Artiga Giorgi, Heno Ferreira Lopes, Fernanda Marciano Consolim-Colombo, Ivonete Sanches Giacometti Kowalski
- Responsible party
- Principal investigator, Grazia Maria Guerra, InCor Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324386
- Sponsor's protocol ID
- 08625112.7.0000.0068
- Other IDs
- 2012-50559-1
- Status last verified
- Oct 2017
- First submitted
- 5 Jun 2017
- Last updated
- 27 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYPERTENSIVE PATIENT ADHERENCE TO TREATMENT: THE USE OF THERAPEUTIC COMMUNICATION ASSOCIATED WITH TECHNOLOGY EDUCATIONAL IN HEALTH PROMOTION"
- ClinicalTrials.gov ID
- NCT03324386
- Acronym / sponsor ID
- 08625112.7.0000.0068
- Keywords
- Hypertension, Tecnology, Nursing, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Luiz Aparecido Bortolotto, Chao Lung Wen, Margarida Vieira, Miriam Harume Tsunemi, Isabela Ribeiro Braga Fistarol, Jefferson Carlos de Oliveira, Dante Marcelo Artiga Giorgi, Heno Ferreira Lopes, Fernanda Marciano Consolim-Colombo, Ivonete Sanches Giacometti Kowalski
- Study start
- 18 Dec 2013 (actual)
- Primary completion
- 25 Apr 2015 (actual)
- Study completion
- 17 Feb 2017 (actual)
- First posted
- 27 Oct 2017 (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.
Few studies show the benefits of educational technologies a support for the control of chronic diseases. The approach known as 'embracement' adopts relational strategies or soft technologies which promote bonding and may impact therapy adherence and quality of life in hypertensive patients.Objectives:To assess the impact of the embracement approach on therapy adherence, quality of life, and the white coat effect in hypertensive outpatients followed in a specialized clinic. This approach may be associated or not with the use of educational technology in a virtual learning environment(VLE) for distance learning (DL) and with use the educational technology in Blended E-learning (E-BLENDED)
Detailed description
Hypertension (HBP) is an important risk factor for cardiovascular disease and has become a common public health problem world wide due to increased longevity. The challenge for next decades is to improve the adherence of patients with chronic degenerative diseases. It is detected that hypertension has been considered a risk factor for determining the incidence of cardiovascular diseases, which directs it to the high cost of treatment in Brazilian public health, therefore the prevention of impairment to health is a priority. Many patients with hypertension do not make the required behavioral changes in your lifestyle, do not forget to take medications or taking medication to fulfil the effective control of the disease. The present study aims to assess the impact of a health promotion program using the Therapeutic Communication and Educational Technology associated of the telemedicine (E-Care of Hypertension) in the performance improvement of patient adherence to treatment. This study aims to evaluation the impact of health promotion program on therapeutic compliance in hypertensive patients, of difficult control of blood pressure levels, with individual guidance through nursing consultation every 20 days, using the approach of "Therapeutic Communication" associated "Educational Technology" for a period of 120 days. For this study will be conducted with 60 patients randomly divided into four groups, according to the care of new cases registered in Ambulatory Hypertension Unit of Heart Institute at Medical School of São Paulo University. The sample will be selected for convenience in accordance with the established day of the week depending on availability of researchers and patients' consent. This approach may be associated or not with the use of educational technology in a virtual learning environment (VLE) for distance learning (DL).This was a prospective randomized clinical study conducted with the following 4 groups of hypertensive patients: This was a prospective randomized clinical study conducted with the following 4 groups of hypertensive patients: Embracement: Group receiving individual orientation required by an embracement strategy characterized by 7 nursing visits at 20-day intervals, for 4 months; Group VLE using a technological education strategy (E-Care of Hypertension) for distance learning (DL) and making 7 nursing visits at 20-day intervals, for 4 months; Control Group that performed 1 nursing visit at baseline and 1 after 120 days.). Group E-blended learning using a technological education strategy (E-Care of Hypertension) which is evaluating the influence of the use of educational technology associated with face-to-face consultation with the health professional (Blended E-learning) and making 7 nursing visits at 20-day intervals, for 4 months. At baseline and after 120 days, the following tools were applied: The Spielberger State-Trait Anxiety Inventory (STAI), the Morisky test, WHOQOL, and ambulatory blood pressure monitoring (ABPM). The VLE group had remote access to the "E-Care of Hypertension" site (6 specific educational modules).The E-BLENDED Group had acess to "E-Care of Hypertension" site (6 specific educational modules) with the presence of the nurse.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- VLE Group use the technology in a virtual learning environment(VLE) for distance learning (DL), HYBRID Group use the educational technology in the E-blended mode leraning, A Group he use of embracement strategy (relational strategies).
| Arm | Type | Receives |
|---|---|---|
| Individual Orientation | Experimental | Behavioral: Experimental: Individual Orientation, Behavioral: Experimental: VLE for Distance LearningThis was a prospective randomized clinical study conducted with the following 4 groups of hypertensive patients: Experimental: individual orientation: receiving individual orientation required by an embracement strategy characterized by 7 nursing visits at 20-day intervals, for 4 months);The ntervention is composed by relational strategies characterized by interpersonal relationships |
| VLE for Distance Learning | Experimental | Behavioral: Experimental: Individual Orientation, Behavioral: Experimental: E-blended LerarningThis was a prospective randomized clinical study conducted with the following 4 groups of hypertensive patients:Experimental: a technological education strategy for distance learning (DL), using a technological education strategy (E-Care of Hypertension) for Distance Learning (DL) characterized by 7 nursing visits at 20-day intervals, for 4 months). The intervention is composed by the use of equipment-oriented techniques or audio-visual aids in educational environments remotely accessed for health education specifically for hypertensive patients |
| E-blended Learning | Experimental | Behavioral: Experimental: Individual Orientation, Behavioral: Experimental: VLE for Distance Learning, Behavioral: Experimental: E-blended Lerarning, Other: Conventional Therapy - Control GroupThis was a prospective randomized clinical study with the patient received experimental intervention: a technological education strategy with E-blended Learning modality with E-Care of Hypertension, associated with face-to-face consultation with the health professional and making 7 nursing visits at 20-day intervals, for 4 months. The intervention is composed by the use of equipment-oriented techniques or audio-visual aids in presential educational environments intended for health education specifically for hypertensive patients |
| No intervention | No intervention | –No type of intervention was performed making 2 nursing visits at baseline and 1 after 120 days (No intervention) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have the medical diagnosis of arterial hypertension,
- Have blood pressure levels equal or above 140 mmHg for systolic blood pressure (SBP), and equal or above 90 mmHg for diastolic blood pressure (DBP),
- Must be able to swallow tablets and under drug treatment with antihypertensives,
- Have digital accessibility through smart phones, tablets or notebooks and PCs.
Key exclusion criteria (3 listed)
- Patients with important cognitive impairment will be considered excluded, that is, with poor understanding of simple questions,
- Clinical diagnosis of Alzheimer's disease, or chorea diseases that lead to cognitive impairment such as senile dementia,
- Diagnosis of insulin dependent diabetes. -
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 |
|---|---|---|
| Experimental: Individual OrientationThis approach may be individual orientation with by an embracement strategy (relational strategies) may be making 7 nursing visits at 20-day intervals, for 4 month. | Behavioural | E-blended Learning, Individual Orientation, VLE for Distance Learning |
| Experimental: VLE for Distance LearningExperimental: This approach may be associated with the use of educational technology (E-Care of Hypertension) in a virtual learning environment(VLE) for distance learning (DL) consultation with the health professional and making 7 nursing visits at 20-day intervals, for 4 months | Behavioural | E-blended Learning, Individual Orientation |
| Experimental: E-blended LerarningThis approach may be associated with the use of educational technology (E-Care of Hypertension) in the blended e-learning mode associated with face-to-face with the health professional and making 7 nursing visits at 20-day intervals, for 4 months | Behavioural | E-blended Learning, VLE for Distance Learning |
| Conventional Therapy - Control GroupThis approach may be individual orientation with conventional therapy may be making 2 nursing visits at baseline and 1 after 120 days, | Other | E-blended Learning |
Primary outcome
measure blood arterial pressure
Time frame: 4 months
At the first nurse interview (day 0: randomization), a questionnaire was used to obtain information related to general data, habits, history of disease, other risk factors for cardiovascular disease, and prescribed medications. This questionnaire was used only to characterize the adherence behavior and the risk factors at the beginning the study, but was not used to evaluate modifications of behavior during the study. Body weight and height were measured. Three consecutive measurements of BP were taken after the patient had rested for 5 min in the supine position.
Ambulatory Blood Pressure monitoring
Time frame: 4 months
Ambulatory BP monitoring was recorded at day ) in randomization and 120 days of follow-up for 24 h with a noninvasive ABPM (Space Labs 90207 monitor; Space Labs, Redmond, WA) with an appropriate-sized cuff. The monitor was placed on the nondominant arm and was set to take BP readings every 10 min during the day and every 20 min at nigh
Pill count
Time frame: up to 4 months
count of the compliments dispensed by the pharmacy and count of the empty blisters delivered in the consultation
2 secondary outcomes
The brief version of the World Health Organization quality of life (WHOQOL-BREF)
Time frame: 4 months
The Duke University Religion Index (DUREL) for a brief measure of religiosity that can be included between religion and health outcomes.
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Individual Orientation, Experimental: VLE for Distance Learning and Experimental: E-blended Lerarning in people with Medication Nonadherence and Hypertension, Resistant to Conventional Therapy, run by University of Sao Paulo General Hospital.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
measure blood arterial pressure (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2017.