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Diabetes Mellitus, Type 2ENURSINNCT02758275

Teaching: Individual to Increase Adherence to Therapeutic Regimen in Hypertension Arterial and/or Diabetes Type 2

A study testing Teaching: Individual (5606) in people with Diabetes Mellitus, Type 2 and Hypertension, run by Universidad Industrial de Santander at 2 sites in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to improve the adherence of therapeutic regimen in people with hypertension arterial and/or diabetes mellitus type 2. Our hypothesis is the nursing intervention "Teaching: Individual", is more effective to increase adherence of therapeutic regimen in people with hypertension arterial… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2, Hypertension
What is being tested?
Teaching: Individual (5606)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesColombia
Study dates
28 Apr 2016to 15 Sep 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult population ≥ 18 years old
  • Medical diagnosis of hypertension arterial and/or diabetes mellitus type 2.
  • Attendees cardiovascular risk programs of Empresa Social del Estado Instituto de Salud de Bucaramanga (ISABU)
  • People totally independent of their care.
  • Access to a fixed telephone line or mobile itself
  • Be residents of Bucaramanga

Who cannot join

  • Changes in the mental sphere. Abbreviated Mental Test (Minimental) and Yesavage depression test.
  • Communication limitations or chronic or serious alterations that make it hard compression of interventions.
  • Subjects who are participating in a research study currently or during the last six months.

Trial locations and contacts

2 sites in 1 country.

Colombia2 sites

  • Empresa Social del Estado Instituto de Salud de Bucaramanga (ESE ISABU)

    Bucaramanga, Santander Department, 680001393

  • Nursing School, Universidad Industrial de Santander

    Bucaramanga, Santander Department, 680002212

Other trials in Colombia

About this study

Official title: Efficacy of Nursing Intervention "Teaching: Individual" to Increase Adherence to Therapeutic Regimen in People With Hypertension Arterial and/or Diabetes Mellitus Type 2

The purpose of this study is to improve the adherence of therapeutic regimen in people with hypertension arterial and/or diabetes mellitus type 2. Our hypothesis is the nursing intervention "Teaching: Individual", is more effective to increase adherence of therapeutic regimen in people with hypertension arterial and/or diabetes mellitus type 2, than usual care.

Read the detailed description

Introduction: The hypertension arterial and diabetes mellitus are chronic diseases with a high burden of disease. It affects approximately 25% of the adult population worldwide and is an important risk factors for global mortality. As for the diabetes, worldwide there are about 346 million people with diabetes and 80% of them live in countries with low and middle income. The recommendations for treating of these diseases includes the pharmacological treatment and modification of lifestyle: salt restriction, moderation in alcohol consumption, high consumption of fruits and vegetables, low-fat diet, weight reduction and regular physical activity. The adherence to these guidelines are essential keys to success in handling these pathologies. The lack of adherence to the prescribed treatment regimen remains a problem among patients with long-term treatment.

Objective: To evaluated the efficacy of nursing intervention "Teaching: Individual" compared with usual care, to increase adherence of therapeutic regimen in people with hypertension arterial and/or diabetes mellitus type 2.

Methods: Randomized controlled trial. 200 patients with hypertension arterial and/or diabetes mellitus type 2 attending cardiovascular risk programs of Bucaramanga, Colombia will include . Nursing intervention to evaluate is "Teaching: Individual" consisting in six educational sessions. The investigators will measure 0, 6 y 12 months: Treatment Behavior: Illness or Injury (1609) (adherence treatment), glycosylated hemoglobin (HbA1c) and systolic blood pressure for 24 hours. Base characteristics of the groups will be compare through chi-square/Fisher´s exact or Students-T/Mann-Whitney U test. Outcomes will be evaluate by paired T-tests or Wilcoxon test at different follow-up times and statistical significance with p-value < 0.05 will considered.

Being tested
Teaching: Individual (5606)
Keywords
Medication adherence, Patient compliance, Diabetes mellitus, Type 2, Hypertension, Nursing, Nursing process, Teaching, Randomized controlled trial
Medical subject headings
Diabetes Mellitus, Type 2, Hypertension, Medication Adherence, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Teaching: Individual (5606)Behavioural

    Usual care and Teaching: Individual (5606): It consists of 6 educational sessions:

    1. Behavior Modification (4360) Promotion of a behavior change.
    2. Teaching Disease Process (5602) Assisting the patient to understand information related to a specific disease process.
    3. Teaching: Prescribed Medication (5616) Preparing a patient to safely take prescribed medications and monitor for their effects.
    4. Teaching: Prescribed Diet (5614) Preparing a patient to correctly follow a prescribed diet.
    5. Teaching: Prescribed Exercise (5612) Preparing a patient to achieve and/or maintain a prescribed level of activity.
    6. Coping Enhancement (5230) Assisting a patient to adapt to perceived stressors, changes, or threats that interfere with meeting life demands and roles.
Study groups in NCT02758275
Study groupRoleWhat they receive
Teaching: Individual (5606)ExperimentalPeople will receive an education session per month for a period of six months with an average duration of 30 minutes. These will be performed by nurses outside the collection of phase base line and follow-up measurements, previously trained for the purpose.
Receives: Behavioral: Teaching: Individual (5606)
Usual careNo interventionPeople will continue to receive usual care in the health center where they usually assist to medical controls.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of mean score adherence to treatment from baseline at 6 and 12 months

    Measured by Treatment Behavior: Illness or Injury (1609)

    Measured: 6 and 12 months

Secondary outcomes (2)

  1. Changes of mean score glycosylated hemoglobin from baseline at 6 and 12 months

    Measured in peripheral venous blood

    Measured: 6 and 12 months

  2. Changes of mean systolic blood pressure from baseline at 6 and 12 months

    Measured by ambulatory blood pressure monitoring

    Measured: 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2016 (estimated)
  2. Study start28 Apr 2016
  3. Primary completion21 Jul 2016
  4. Study completion15 Sep 2017

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02758275
Sponsor's protocol ID
1861
Acronym
ENURSIN
Status last verified
Oct 2017
First submitted
27 Apr 2016
Last updated
19 Oct 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Romero S, Parra D, Sánchez J, Rojas L. Adherence to therapeutic regimen of hypertension andtype-2 diabetes patients in Bucaramanga, Colombia . Rev Univ Ind Santander Salud. 2017; 49(1): 37-44. DOI: http://dx.doi.org/10.18273/revsal.v49n1-2017004

  • López L, Romero S, Parra D, Rojas L. Adherence to treatment: concept and measurement. Hacia promoc. salud. 2016; 21(1): 117-137. DOI: 10.17151/hpsal.2016.21.1.10

  • Romero Guevara SL, Parra DI, Rojas LZ. "Teaching: Individual" to increase adherence to therapeutic regimen in people with hypertension and type-2 diabetes: protocol of the controlled clinical trial ENURSIN. BMC Nurs. 2019 Jun 4;18:22. doi: 10.1186/s12912-019-0344-0. eCollection 2019.

    PubMed 31171916

Questions about this trial

What is this clinical trial studying?

A study testing Teaching: Individual (5606) in people with Diabetes Mellitus, Type 2 and Hypertension, run by Universidad Industrial de Santander at 2 sites 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 6 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 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

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?

Changes of mean score adherence to treatment from baseline at 6 and 12 months (time frame: 6 and 12 months). 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 NCT02758275, which also lists 3 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 Oct 2017.

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