Type 2 Diabetes MellitusNCT03729323
Motivational Interviewing in the Control of Arterial Hypertension and Type 2 Diabetes Mellitus
A study testing Motivational interviewing and Nursing Consultation in people with Type 2 Diabetes Mellitus and Systemic Arterial Hypertension, run by Hospital Nossa Senhora da Conceicao at 1 site in Brazil.
Trial summary
The goal of this study is to evaluate the effectiveness of Nursing Consultation based on the assumptions and techniques of Motivational Interviewing for the control of Type 2 diabetes mellitus with associated diagnosis of Systemic Arterial Hypertension in primary healthcare. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Systemic Arterial Hypertension
- What is being tested?
- Motivational interviewing and Nursing Consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteBrazil
- Study dates
- 11 Apr 2018to 12 Mar 2021
- 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
- Being 18 years old or older;
- Having diagnosis of Type 2 Diabetes Mellitus and Systemic Arterial Hypertension.
- Being registered in the programmatic action of the clinics under study under risk stratum 3;
Who cannot join
- Being assessed at a risk stratum other than 3 at the time of the first meeting with the control and intervention group;
- Showing a cognitive deficit or associated diseases compromising the patient's mental faculties
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Nossa Senhora da Conceição Hospital
Porto Alegre, Rio Grande do Sul, 91350-200
About this study
Official title: Nursing Consultation Based on Motivational Interviewing as a Strategy for the Control of Type 2 Diabetes Mellitus and Systemic Arterial Hypertension in Primary Healthcare: A RANDOMIZED CLINICAL TRIAL
The goal of this study is to evaluate the effectiveness of Nursing Consultation based on the assumptions and techniques of Motivational Interviewing for the control of Type 2 diabetes mellitus with associated diagnosis of Systemic Arterial Hypertension in primary healthcare.
Read the detailed description
Type 2 Diabetes Mellitus and Systemic Arterial Hypertension are major challenges to health systems worldwide, and control, adherence and promotion of self-care are the cornerstone of their management. In this context, an adequate therapist-patient relationship is the key to the success of these interventions in healthcare, and nurses have a recognized and outstanding role in improving adherence and care results in chronic diseases. Motivational Interviewing (MI) emerges as a skillful method of counseling that has proven to be effective in promoting changes in a wide variety of health-related behaviors, including hypertension and diabetes. Despite the increasing number of international studies in different health fields, the scientific production that assess the applicability of Motivational Interviewing to chronic diseases in the Brazilian setting is still modest. Recent studies suggest the need for further research involving the discussion and improvement of studies utilizing Motivational Interviewing in Brazil, as well as in other countries around the world, for better outlook on this area of investigation. Therefore, this study intends to contribute to this perspective and aims to investigate the effectiveness of this care strategy in individual Nursing consultations for people with DM2 and SAH who are being treated in three Primary Healthcare Clinics in the Northern Area of Porto Alegre - RS , Brazil, which are an integral part of the Grupo Hospitalar Conceição (GHC) Community Health Service (SSC). GHC treats patients from the Brazilian public health system exclusively, with universal and free access, and the SSC is comprised of 16 primary care and mental health services, caring for a population of 105,000 inhabitants in the northern and eastern areas of Porto Alegre, RS, Brazil. This will be a randomized, controlled, parallel and double-blind clinical trial to be conducted in the period from June to September, 2018.
MAIN GOAL: To evaluate the effectiveness of Nursing Consultation based on the assumptions and techniques of Motivational Interviewing in the control of Type 2 Diabetes Mellitus with associated diagnosis of Systemic Arterial Hypertension in primary healthcare.
SPECIFIC GOALS:
- To characterize participants in terms of sociodemographic and economic profile, health history, and life habits;
- To monitor and assess glycemic and pressure goals before and after intervention;
- To estimate the prevalence of adherence to drug therapy and healthy life habits among participants before and after intervention;
- To assess self-efficacy for participants' self-care before and after intervention.
- To evaluate the Level of Importance and Confidence to change unhealthy behaviors among participants with DM2 and SAH, before and after intervention.
- Being tested
- Motivational interviewing, Nursing Consultation
- Keywords
- Motivational Interviewing, Type 2 Diabetes Mellitus, Systemic Arterial Hypertension, Chronic Diseases, Self-care
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
In Diabetes and hypertension, nursing consultations to support the care should be focused on their educational component the orientation of measures that prove to reduce blood pressure, improve the glycemic indices, the lipid profile and the Cardiovascular risk classification, among them: adherence to drug therapy, proper diet, body weight maintenance, stimulating active life and regular physical exercise, reducing alcoholic beverage consumption, reducing stress and abandoning Smoking. In this group, these care will be addressed based on the principles and techniques of the Motivational Interviewing.
Nursing ConsultationBehavioural
In Diabetes and hypertension, nursing consultations to support the care should be focused on their educational component the orientation of measures that prove to reduce blood pressure, improve the glycemic indices, the lipid profile and the Cardiovascular risk classification, among them: adherence to drug therapy, proper diet, body weight maintenance, stimulating active life and regular physical exercise, reducing alcoholic beverage consumption, reducing stress and abandoning Smoking. In this group, these care will be approached in a conventional manner, as routine of the services, based on the recommendations of the Primary Care Strategy Notebooks for the care of chronic conditions in DM2 and SAH and the SSC-GHC Institutional Protocol for SAH and DM2 Patient Care.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Motivational Interviewing | Experimental | INTERVENTION GROUP: In this group, Diabetics and Hypertensives will attend two Nursing Consultation sessions based on the assumptions and techniques of Motivational Interviewing with a certified nurse with specific 20-hour theoretical and practical training for this approach style. Receives: Behavioral: Motivational interviewing |
| Nursing Consultation | Active comparator | CONTROL GROUP: In this group, Diabetics and Hypertensives will attend two conventional nursing consultation sessions aimed at self-care, with a untrained nurse for the use of motivational interviewing, based on the recommendations of the Primary Care Strategy Notebooks for the care of chronic conditions in Diabetes Mellitus and Arterial Hypertension and the SSC-GHC Institutional Protocol for SAH and DM2 Patient Care. Receives: Behavioral: Nursing Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin
Mean difference between laboratory examination of glycated hemoglobin at baseline and 3 months after the end of two Nursing Consultation sessions as a intervention;
Measured: 3 months after the end of two Nursing Consultation sessions as a intervention
Blood pressure
Mean difference of systolic and diastolic blood pressure at baseline and 3 months after the end of two Nursing Consultation sessions as a intervention;
Measured: 3 months after the end of two Nursing Consultation sessions as a intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start11 Apr 2018
- Primary completion20 Jun 2019
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical-behavioral
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nossa Senhora da Conceicao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Demétrio Faustino da Silva, Hospital Nossa Senhora da Conceicao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729323
- Sponsor's protocol ID
- Grupo Hospitalar Conceicao
- Status last verified
- Mar 2021
- First submitted
- 7 Oct 2018
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Steffen PLS, Mendonca CS, Meyer E, Faustino-Silva DD. Motivational Interviewing in the Management of Type 2 Diabetes Mellitus and Arterial Hypertension in Primary Health Care: An RCT. Am J Prev Med. 2021 May;60(5):e203-e212. doi: 10.1016/j.amepre.2020.12.015. Epub 2021 Feb 24.
PubMed 33637368
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Consultation Based on Motivational Interviewing as a Strategy for the Control of Type 2 Diabetes Mellitus and Systemic Arterial Hypertension in Primary Healthcare: A RANDOMIZED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT03729323
- Acronym / sponsor ID
- Grupo Hospitalar Conceicao
- Keywords
- Motivational Interviewing, Type 2 Diabetes Mellitus, Systemic Arterial Hypertension, Chronic Diseases, Self-care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Hospital Nossa Senhora da ConceicaoUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 2 Nov 2018 (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.
The goal of this study is to evaluate the effectiveness of Nursing Consultation based on the assumptions and techniques of Motivational Interviewing for the control of Type 2 diabetes mellitus with associated diagnosis of Systemic Arterial Hypertension in primary healthcare.
Detailed description
Type 2 Diabetes Mellitus and Systemic Arterial Hypertension are major challenges to health systems worldwide, and control, adherence and promotion of self-care are the cornerstone of their management. In this context, an adequate therapist-patient relationship is the key to the success of these interventions in healthcare, and nurses have a recognized and outstanding role in improving adherence and care results in chronic diseases. Motivational Interviewing (MI) emerges as a skillful method of counseling that has proven to be effective in promoting changes in a wide variety of health-related behaviors, including hypertension and diabetes. Despite the increasing number of international studies in different health fields, the scientific production that assess the applicability of Motivational Interviewing to chronic diseases in the Brazilian setting is still modest. Recent studies suggest the need for further research involving the discussion and improvement of studies utilizing Motivational Interviewing in Brazil, as well as in other countries around the world, for better outlook on this area of investigation. Therefore, this study intends to contribute to this perspective and aims to investigate the effectiveness of this care strategy in individual Nursing consultations for people with DM2 and SAH who are being treated in three Primary Healthcare Clinics in the Northern Area of Porto Alegre - RS , Brazil, which are an integral part of the Grupo Hospitalar Conceição (GHC) Community Health Service (SSC). GHC treats patients from the Brazilian public health system exclusively, with universal and free access, and the SSC is comprised of 16 primary care and mental health services, caring for a population of 105,000 inhabitants in the northern and eastern areas of Porto Alegre, RS, Brazil. This will be a randomized, controlled, parallel and double-blind clinical trial to be conducted in the period from June to September, 2018.
MAIN GOAL: To evaluate the effectiveness of Nursing Consultation based on the assumptions and techniques of Motivational Interviewing in the control of Type 2 Diabetes Mellitus with associated diagnosis of Systemic Arterial Hypertension in primary healthcare.
SPECIFIC GOALS:
- To characterize participants in terms of sociodemographic and economic profile, health history, and life habits;
- To monitor and assess glycemic and pressure goals before and after intervention;
- To estimate the prevalence of adherence to drug therapy and healthy life habits among participants before and after intervention;
- To assess self-efficacy for participants' self-care before and after intervention.
- To evaluate the Level of Importance and Confidence to change unhealthy behaviors among participants with DM2 and SAH, before and after intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Clinical-behavioral
| Arm | Type | Receives |
|---|---|---|
| Experimental: Motivational Interviewing | Experimental | Behavioral: Motivational interviewingINTERVENTION GROUP: In this group, Diabetics and Hypertensives will attend two Nursing Consultation sessions based on the assumptions and techniques of Motivational Interviewing with a certified nurse with specific 20-hour theoretical and practical training for this approach style. |
| Nursing Consultation | Active comparator | Behavioral: Nursing ConsultationCONTROL GROUP: In this group, Diabetics and Hypertensives will attend two conventional nursing consultation sessions aimed at self-care, with a untrained nurse for the use of motivational interviewing, based on the recommendations of the Primary Care Strategy Notebooks for the care of chronic conditions in Diabetes Mellitus and Arterial Hypertension and the SSC-GHC Institutional Protocol for SAH and DM2 Patient Care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being 18 years old or older;
- Having diagnosis of Type 2 Diabetes Mellitus and Systemic Arterial Hypertension.
- Being registered in the programmatic action of the clinics under study under risk stratum 3;
Key exclusion criteria (2 listed)
- Being assessed at a risk stratum other than 3 at the time of the first meeting with the control and intervention group;
- Showing a cognitive deficit or associated diseases compromising the patient's mental faculties
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 |
|---|---|---|
| Motivational interviewingIn Diabetes and hypertension, nursing consultations to support the care should be focused on their educational component the orientation of measures that prove to reduce blood pressure, improve the glycemic indices, the lipid profile and the Cardiovascular risk classification, among them: adherence to drug therapy, proper diet, body weight maintenance, stimulating active life and regular physical exercise, reducing alcoholic beverage consumption, reducing stress and abandoning Smoking. In this group, these care will be addressed based on the principles and techniques of the Motivational Interviewing. | Behavioural | Experimental: Motivational Interviewing |
| Nursing ConsultationIn Diabetes and hypertension, nursing consultations to support the care should be focused on their educational component the orientation of measures that prove to reduce blood pressure, improve the glycemic indices, the lipid profile and the Cardiovascular risk classification, among them: adherence to drug therapy, proper diet, body weight maintenance, stimulating active life and regular physical exercise, reducing alcoholic beverage consumption, reducing stress and abandoning Smoking. In this group, these care will be approached in a conventional manner, as routine of the services, based on the recommendations of the Primary Care Strategy Notebooks for the care of chronic conditions in DM2 and SAH and the SSC-GHC Institutional Protocol for SAH and DM2 Patient Care. | Behavioural | Nursing Consultation |
Primary outcome
Glycated hemoglobin
Time frame: 3 months after the end of two Nursing Consultation sessions as a intervention
Mean difference between laboratory examination of glycated hemoglobin at baseline and 3 months after the end of two Nursing Consultation sessions as a intervention;
Blood pressure
Time frame: 3 months after the end of two Nursing Consultation sessions as a intervention
Mean difference of systolic and diastolic blood pressure at baseline and 3 months after the end of two Nursing Consultation sessions as a intervention;
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 16 Mar 2021.
- Derived from this study: PubMed 33637368Steffen PLS, Mendonca CS, Meyer E, Faustino-Silva DD. Motivational Interviewing in the Management of Type 2 Diabetes Mellitus and Arterial Hypertension in Primary Health Care: An RCT. Am J Prev Med. 2021 May;60(5):e203-e212. doi: 10.1016/j.amepre.2020.12.015. Epub 2021 Feb 24.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing and Nursing Consultation in people with Type 2 Diabetes Mellitus and Systemic Arterial Hypertension, run by Hospital Nossa Senhora da Conceicao at 1 site in Brazil.
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 3 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: finished, as of the sponsor's last update on 16 Mar 2021. 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 Brazil. 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?
Glycated hemoglobin (time frame: 3 months after the end of two Nursing Consultation sessions as a 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 NCT03729323, which also lists 1 linked publication.
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 16 Mar 2021.