- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05660928
Control of Hypertension and diAbetes in MINas Gerais (CHArMING)
Control of Hypertension and diAbetes in MINas Gerais: Assessment of the Impact of Implementing a Multidimensional Strategy for Management of Patients With Systemic Arterial Hypertension and Diabetes Mellitus in Primary Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This scale up implementation study has mixed-methods, and comprehends four steps: (1) needs assessment, (2) baseline period, (3) cluster RCT and (4) qualitative study. The RE-AIM planning and evaluation framework will be used in this research project, which includes: reach (R), efficacy (E), adoption (A), implementation (I), and maintenance (M). The Adaptation Framework might be used as well, in case adaptations need to be conducted during the intervention, taking into account the COVID-19 pandemic and possible new waves.
- A standardized structured questionnaire will be developed with open questions about the physical and technological structure, human resources and challenges managing patients with hypertension and DM, in order to carry out a brief situational diagnosis.
- A baseline period of three months will be established to assess the basal condition of patients. Individuals will be assessed for blood pressure and glycohemoglobin measurements; functional performance (2-minute step test); anthropometric measurements (weight, height, and waist circumference); physical inactivity; alcohol consumption; smoking; and food consumption markers.
- A two-arm parallel cluster RCT will be conducted, with a baseline period of three months and a subsequent follow-up period of 12 months from the start of the intervention. To avoid possible contamination within the same primary care unit, randomization will take place at a primary care centre level: each centre will be randomized to the control or the intervention arm, rather than individual patients. Randomization will be performed by computer software and stratified by geographic location and municipality, to ensure balance between arms.
- At the end of the cluster-randomized controlled trial, another qualitative study will be carried out using the FG technique, in order to assess barriers and suggestions for improvement of each component of the implemented multidimensional strategy.
To calculate the sample size, the investigators took into account the proportion of patients with controlled hypertension (33%) and DM (37%) observed at baseline in the pilot study (data not published), and an absolute increase of 6% in these proportions one year after the implementation of the intervention, with a power of 0.80, level of significance of 0.05 and intra cluster correlation coefficient of 0.026. The calculated sample was 34 primary care centres, 17 in each arm, with a minimum of 148 participants in each centre. As the total number of primary care centres in the five municipalities is 35, the investigators planned to include one extra unit in the intervention arm. Taking into account a drop out rate of up to 17.8%, the total number of included individuals will be 180.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Antonio Ribeiro, PhD
- Phone Number: +553133079201
- Email: alpr1963br@gmail.com
Study Contact Backup
- Name: Milena Marcolino, PhD
- Phone Number: +553133079201
- Email: milenamarc@gmail.com
Study Locations
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brazil, 30130-100
- Federal University of Minas Gerais
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Primary Health Care - Basic health unit with internet availability and complete team, including a Brazilian doctor or with a proficiency test in the Portuguese language.
Patients
- Adult patients (from 18 years-old), diagnosed with hypertension and/or DM, registered in the medical record.
Subproject cluster randomised controlled trial. All of the above criteria and the following additional criteria:
- Patients aged ≥ 18 years-old, with a diagnosis of hypertension and diabetes mellitus, registered in the medical record;
- Absence of contraindications to physical activity, according to the assistant physician's assessment;
- In intervention levels II and III, it will be a prerequisite that the participant has a smartphone.
Exclusion Criteria:
- Patients with terminal illness, with a life expectancy lower than 12 months according to the physician's evaluation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Eighteen primary care centers will be randomized to the intervention arm, which consists of a multidimensional strategy, with a multidisciplinary approach, for the management of patients with hypertension and diabetes in the primary care setting. It is going to include:
|
Multidimensional intervention, with mutidisciplinary approach.
|
No Intervention: Usual care
Seventeen primary care centers will be randomized to usual care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite outcome of proportion of patients with controlled disease
Time Frame: 12 months
|
(i) for hypertension, the proportion (%) of patients with systolic blood pressure (SBP) <140 mmHg and diastolic blood pressure (DBP) < 90 mmHg; (ii) for diabetes, the proportion (%) of patients with glycohemoglobin ≤ 7% if the age < 60 years, or < 8% if the age is ≥ 60 years; (iii) for those with both hypertension and diabetes, proportion (%) of patients with both diseases controlled.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients with controlled hypertension
Time Frame: 12 months
|
The proportion (%) of patients with systolic blood pressure (SBP) <140 mmHg and diastolic blood pressure (DBP) < 90 mmHg
|
12 months
|
Proportion of patients with controlled diabetes
Time Frame: 12 months
|
The proportion (%) of patients with glycohemoglobin ≤ 7% if the age < 60 years, or < 8% if the age is ≥ 60 years
|
12 months
|
Change in blood pressure
Time Frame: 12 months
|
The mean difference in delta SBP and DBP (mmHg) in patients with hypertension, when comparing the intervention and the control groups, in 12 months
|
12 months
|
Change in glycohemoglobin
Time Frame: 12 months
|
The mean difference in delta glycohemoglobin (%) in patients with diabetes, when comparing the intervention and the control groups, in 12 months
|
12 months
|
Number of blood pressure measurements
Time Frame: 12 months
|
Number of blood pressure measurements per patient with hypertension in 12 months
|
12 months
|
Number of glycohemoglobin measurements
Time Frame: 12 months
|
Number of glycohemoglobin measurements per patient with diabetes in 12 months
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients who participated in group activities in 12 months.
Time Frame: 12 months
|
Percentage of patients with hypertension and diabetes who participated at least once in group activities in 12 months.
|
12 months
|
Total follow-up time of patients
Time Frame: 12 months
|
Time in months between the first consultation after enrollment and last consultation during the study period
|
12 months
|
Number of consultations during the follow-up time
Time Frame: 12 months
|
Number of consultations with medical doctors and nurses during the follow-up time
|
12 months
|
Performance in the 2-minute standing gait test
Time Frame: 6 and 12 months
|
The difference in the number of steps (delta from the beginning) in the 2-minute standing gait test within 6 months and 12 months.
|
6 and 12 months
|
Performance in the hand grip strength test
Time Frame: 6 and 12 months
|
The difference in the hand grip strength measured by in kgf (delta from the beginning) within 6 months and 12 months.
|
6 and 12 months
|
Change in the body weight
Time Frame: 12 months
|
The change in the body weight (kg) in the follow-up time
|
12 months
|
Change in the body mass index
Time Frame: 12 months
|
The change in the body mass index in the follow-up time
|
12 months
|
Change in the waist circumference
Time Frame: 12 months
|
The change in the waist circumference (cm) in the follow-up time
|
12 months
|
Program adherence
Time Frame: 12 months
|
Total follow-up time (time between the first consultation after enrollment and last consultation); median time between medical and nurse consultations; number of consultations during follow-up time, number of groups conducted at each primary care centre during the follow-up; participation of patients at the educational groups; adherence to CDSS recommendations (intervention group only).
|
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 55598822.0.0000.5149
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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