NCT03250702

Brief Summary

The aim of the Dar es Salaam Urban Cohort Hypertension Study (DUCS-HTN) was to determine the current prevalence, risk factors, and barriers to diagnosis and treatment for hypertension in Dar es Salaam, Tanzania. Few previous studies in Tanzania have analyzed the modifiable determinants of high BP as well as barriers to diagnosis and treatment of hypertension. DUCS-HTN is a cohort of adults living in the Ukonga ward of Dar es Salaam who had been registered in the Dar es Salaam Health and Demographic Surveillance System (HDSS) in 2011. Due to the large size of Ukonga, the investigators chose to randomly sample two of the seven neighborhoods that compose Ukonga and then conducted a census of these two randomly selected neighborhoods, Mwembe Madafu and Markazi. The investigators attempted to contact all 4896 HDSS participants who were at least 40 years of age and lived in one of these neighborhoods. Trained interviewers conducted face-to-face interviews and physical examinations in participants' homes from March to June 2014. Follow-up visits were conducted from April to June 2015. Among 4896 potentially eligible participants from the HDSS baseline survey, 3604 (74%) were still living at the same address in 2014. Of these, 2290 (64%) enrolled in the DUCS-HTN study. Of the participants enrolled at baseline, 1752 (77%) participated in the follow-up study. Blood pressure measurements Trained interviewers measured blood pressure with digital blood pressure monitors (15 Omron M2 and 5 Beurer BM 40 monitors). Standard, large, and extra-large cuff sizes were used according to the size of a participant's arm. Blood pressure was measured three times with at least a 5-minute rest before the first measurement and 3-minute rests between each subsequent measurement. Blood pressure was taken on the left arm with the participant seated and the arm straight at heart level. Usual blood pressure values were calculated as the mean of the second and third readings. If a second visit was conducted, usual blood pressure values were defined as the mean of the second and third readings at both the first and second visits. Hypertension was defined as SBP≥140 mmHg or DBP≥90 mmHg, or self-reported use of anti-hypertensive medication. Grade I hypertension was defined as SBP of 140 to 159 or DBP of 90 to 99 mmHg; grade II hypertension was defined as SBP of 160 to 179 or DBP of 100 to 109 mmHg; and grade III hypertension was defined as SBP≥180 or DBP≥110 mmHg. Hypertension control was defined as current antihypertensive use and blood pressure of less than 140/90 mmHg. If a participant was found to have grade I or II hypertension, a second visit was scheduled, at least three days later. Those with grade III hypertension at the last reading of the first visit or grade I or II hypertension at the last reading of the second visit were told that they had high blood pressure, advised to see a health professional and were given a referral letter. In addition, a second visit and blood pressure reading was scheduled for a random sample of one-fifth of participants, who were selected for additional blood, urinary, and dietary measurements. Assessment of covariates All participants were administered a socio-demographic and lifestyle questionnaire and had their height, weight, and waist and hip circumference measured. Some demographic information (age, sex, neighborhood, religion, and assets used to create a household wealth index) was previously recorded during the HDSS baseline. Information on household health insurance coverage was collected in 2015 as part of routine HDSS updates. Standard protocols were used to take anthropometric measurements. Participants were weighed with minimal clothing using a digital scale (Seca, Germany) to the nearest 0.1kg and height was measured, with participants not wearing shoes, to the nearest 1cm. Body mass index (BMI) was calculated as the ratio of weight in kilograms to height in meters squared (kg/m2) and categorized according to WHO categories. The Global Physical Activity Questionnaire (GPAQ) was used to assess physical activity for work, transportation, and leisure. The investigators defined physical inactivity according to WHO guidelines. Number of servings of alcoholic beverages consumed was reported over the past 30 days. The investigators assumed 14 grams of alcohol as a standard drink portion size. A household wealth index was created through a principal component analysis of household characteristics and assets, and was categorized into quintiles. In the follow-up visit, participants were asked about their health over the past year and the reasons for not seeking hypertension care. A subsample of \~ one fifth of the participants completed a food frequency questionnaire, two 24-hour dietary recalls, a 24-hour urine collection for sodium, creatinine, protein, and potassium, and had capillary total cholesterol and blood glucose measurements taken.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,290

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

1.3 years

First QC Date

August 11, 2017

Last Update Submit

August 15, 2017

Conditions

Keywords

TanzaniaObservationalSub-Saharan AfricaTreatment

Outcome Measures

Primary Outcomes (3)

  • Systolic blood pressure

    Continuous variable

    baseline

  • Visited health professional for hypertension care

    Self report of visiting health professional for hypertension care between baseline and follow-up

    1-year follow-up

  • Taking antihypertensive medication

    Self report of taking antihypertensive treatment at time of follow-up

    1-year follow-up

Secondary Outcomes (2)

  • Diastolic blood pressure

    baseline

  • Hypertension

    baseline

Eligibility Criteria

Age40 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

DUCS-HTN is a cohort of adults living in the Ukonga ward of Dar es Salaam who had been registered in the Dar es Salaam Health and Demographic Surveillance System (HDSS) in 2011. Due to the large size of Ukonga, we chose to randomly sample two of the seven neighborhoods that compose Ukonga and then conducted a census of these two randomly selected neighborhoods, Mwembe Madafu and Markazi. We attempted to contact all 4896 HDSS participants who were at least 40 years of age and lived in one of these neighborhoods. Trained interviewers conducted face-to-face interviews and physical examinations in participants' homes from March to June 2014. Follow-up visits were conducted from April to June 2015. Among 4896 potentially eligible participants from the HDSS baseline survey, 3604 (74%) were still living at the same address in 2014. Of these, 2290 (64%) enrolled in the DUCS-HTN study. Of the participants enrolled at baseline, 1752 (77%) participated in the follow-up study.

You may qualify if:

  • Lived in Madafu or Markazi neighborhoods of Ukonga Ward in Tanzania

You may not qualify if:

  • Pregnant
  • Mentally or physically disabled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionObesity

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Global Health

Study Record Dates

First Submitted

August 11, 2017

First Posted

August 16, 2017

Study Start

March 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 17, 2017

Record last verified: 2017-08