Hypertension in Primary Health Care: Lifestyle Change and Blood Pressure Goals

NCT ID: NCT01085890

Last Updated: 2010-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2008-11-30

Brief Summary

The purpose of this study is to determine whether a program that includes 1) group seminars and 2) follow-up visits with blood pressure measurement and motivational interviewing (MI) that is focused on lifestyle change affect blood pressure.

Detailed Description

High blood pressure is common in the population. In an earlier study conducted in our local geographical area, "How is health in Jordbro?" 46% of participants had a systolic blood pressure of >140 millimeters of mercury (mm Hg) and 22% had a diastolic blood pressure >90 mm Hg. 84% of those with known hypertension had a systolic blood pressure of >140. We thus found that many people in our area have heightened blood pressure, and hypothesized that many of these people, particularly those with mild hypertension, probably could be helped with lifestyle-related intervention.

All persons who came to Jordbro Primary Health Care Center during a 6-month period were invited to participate in the current study, and local press announcements were used to recruit additional participants. A total of 301 persons volunteered to participate. A total of 141 of the volunteers had a systolic blood pressure =>140 and/or a diastolic blood pressure of =>90, and these people became the study population. The 141 persons in the study population filled in a questionnaire with general background and lifestyle questions.

Of the 141 persons in the study population, 75 had previously known hypertension and 66 had hypertension that was previously unknown. Participants were then randomized such that an equal number of persons with previously known and previously unknown hypertension were included in a) a treatment group and b) a control group. Background information such as height, weight, pulse, smoking habits, other diseases, and prescription drugs was gathered. Blood sugar and lipid tests were conducted. Participants' family physician were contacted as necessary (e.g., if blood pressure was dangerously high).

The intervention consisted of 2 group seminars with information on hypertension and related lifestyle factors and 2 follow-up visits with each participant in which blood pressure was measured and motivational interviewing took place. The motivational interviewing focused on lifestyle factors, including physical activity, stress, tobacco use, alcohol habits, and diet. After 6 months, a follow-up was done that included blood pressure measurement and completion of the same questionnaire that was filled in at baseline.

Conditions

Blood Pressure; Life Style

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Motivational interviewing group

The participants in this arm had 2 group seminars with information on hypertension and related lifestyle factors. They participated in 2 follow-up visits in which blood pressure was measured and motivational interviewing took place. The motivational interviewing focused on lifestyle factors, including physical activity, stress, tobacco use, alcohol habits, and diet.

Group Type: EXPERIMENTAL

Motivational interviewing

Intervention Type: BEHAVIORAL

The intervention consisted of 2 group seminars with information on hypertension and related lifestyle factors and 2 follow-up visits in which blood pressure was measured and motivational interviewing took place. The motivational interviewing focused on lifestyle factors, including physical activity, stress, tobacco use, alcohol habits, and diet.

Treatment as usual

Participants in this group received treatment as usual for their high blood pressure, but no informational seminars and no extra visits with motivational interviewing and blood pressure measurement.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Motivational interviewing

The intervention consisted of 2 group seminars with information on hypertension and related lifestyle factors and 2 follow-up visits in which blood pressure was measured and motivational interviewing took place. The motivational interviewing focused on lifestyle factors, including physical activity, stress, tobacco use, alcohol habits, and diet.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• => 30 years
• ability to speak Swedish well enough to fill the baseline and follow-up questionnaires, participate in the seminars, and participate in the motivational interviewing

Exclusion Criteria

• < 30 years
• inability to speak Swedish well enough to fill the baseline and follow-up questionnaires, participate in the seminars, and participate in the motivational interviewing

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Karolinska Institutet

Principal Investigators

Lena Holm, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Jordbro Primary Health Care Center

Haninge, , Sweden

Countries

Sweden

References

Al-Windi A. Detection and treatment of hypertension in general health-care practice: a patient-based study. J Hum Hypertens. 2005 Oct;19(10):775-86. doi: 10.1038/sj.jhh.1001902.

Reference Type: BACKGROUND

PMID: 15988540 (View on PubMed)

Al-Windi A. The validity of a questionnaire on medicines used in health care practice: comparison of a questionnaire and computerized medical record survey. Eur J Clin Pharmacol. 2003 Aug;59(4):321-9. doi: 10.1007/s00228-003-0615-1. Epub 2003 Jul 4.

Reference Type: BACKGROUND

PMID: 12845507 (View on PubMed)

Other Identifiers

511025-2672

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KI 2006/1285-31

Identifier Type: -

Identifier Source: org_study_id