Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Enhance Drug Compliance in Response to Home Blood Pressure(BP) Monitoring in Older People

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02551393
Recruitment Status : Unknown
Verified September 2015 by Dr. Sau-nga Fu, The University of Hong Kong.
Recruitment status was:  Not yet recruiting
First Posted : September 16, 2015
Last Update Posted : September 16, 2015
Sponsor:
Collaborator:
Hospital Authority, Hong Kong
Information provided by (Responsible Party):
Dr. Sau-nga Fu, The University of Hong Kong

Brief Summary:

Clinical Trial: The investigators aims at comparing providing validated home BP device, followed by group education of self-management of hypertension as well as self-BP monitoring and appropriate medication in response to home BP reading, followed by nurse follow up with usual care, which may possibly improve older adults with uncontrolled hypertensions drug adherence, and therefore improve their BP level in primary care setting. The investigators will invite total 270 patients from 6 general outpatient clinic (GOPCs) to participate the trial.

Qualitative study: The investigators would also like to evaluate patients' view and operational concerns on self BP monitoring by individually interviewing 30 selected patients from intervention group


Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Home Blood Presssure Monitoring, Education Not Applicable

Detailed Description:

Background Recent oversea randomized control trials have proven effectiveness of lowering clinic and home BP if uncontrolled hypertensive patients were taught to perform home BP monitoring properly with validated BP device. Patients were taught to response to home BP reading (e.g. follow drug regime, or doctor adjust drug according to patients' home BP record)

Study design 1. Prospective cluster randomized control trial, 2. Qualitative individual interview

Aims The investigators aims at comparing providing validated home BP device, followed by group education of self-management of hypertension as well as self-BP monitoring and appropriate medication in response to home BP reading, followed by nurse follow up with usual care, which may possibly improve older adults with uncontrolled hypertensions drug adherence, and therefore improve their BP level in primary care setting. The investigators would also like to evaluate patients' view and operational concerns on self BP monitoring

Subjects Age ≥65 years old Chinese on hypertensive treatment more than 12 months with uncontrolled hypertension by mean clinic BP measurement on the day of recruitment. Uncontrolled hypertension is defined as BP > 140/90mmHg in subjects age < 80; and BP > 150/90mmHg in subjects age≥80. You will be invited to participate if you are willing and capable to perform home BP monitoring by themselves on daily basis.

Sample size 270 (45 people from each clinic); 30 people for qualitative interview

Assignment 3 clinics will be randomly assigned to intervention clinic while the other 3 will be randomly assigned to control clinic (usual care)

Intervention(s) Doctors and Nurses in intervention clinic will receive 1 hour briefing + education on the background, scientific basis and detail of the program during lunch time. Patients from intervention clinics will be invited to attend 2 x 2 hours education group (15-30 subjects / group) ran by clinic nurses and doctors. You will be educated on basic knowledge, management and drug for hypertension in the first session. In the 2nd session, a certified valid Home BP device will be loaned to you for 6- 9 months and you will be taught to perform home BP monitoring, record and response to the BP reading accordingly. Upon completion of session 2, you will be arranged for nurse individual follow up after 4-8 weeks to see your progress and monitoring.

30 people from intervention group will be interviewed individually for your opinion on the program, management of hypertension and performance of home BP monitoring.

Outcome measures BMI (BH/ BW), Waist circumference, Clinic BP (sitting position/ standing position), Lab Test: FBS, Lipid profile, eGFR, Urine PCR, ECG Qualitative data for patient's view on home BP monitoring

Follow up duration 6-9 months

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhance Drug Compliance in Response to Home Blood Pressure(BP) Monitoring in Older People With Uncontrolled Hypertension: a Randomized Controlled Trial
Study Start Date : January 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
Doctors and Nurses in intervention clinic will receive 1 hour briefing + education on the background, scientific basis and detail of the program during lunch time. People from intervention clinics will be invited to attend 2 x 2 hours education group (15-30 subjects / group) ran by clinic nurses and doctors. You will be educated on basic knowledge, management and drug for hypertension in the first session. In the 2nd session, a certified valid Home BP device will be loaned to you for 6-9 months and you will be taught to perform home Blood pressure monitoring, record and response to the BP reading accordingly. Upon completion of session 2, you will be arranged for nurse individual follow up after 4-8 weeks to see their progress and monitoring
Behavioral: Home Blood Presssure Monitoring, Education
Doctors and Nurses in intervention clinic will receive 1 hour briefing + education on the background, scientific basis and detail of the program during lunch time. People from intervention clinics will be invited to attend 2 x 2 hours education group (15-30 subjects / group) ran by clinic nurses and doctors. You will be educated on basic knowledge, management and drug for hypertension in the first session. In the 2nd session, a certified valid Home BP device will be loaned to you for 6-9 months and you will be taught to perform home BP monitoring, record and response to the BP reading accordingly. Upon completion of session 2, you will be arranged for nurse individual follow up after 4-8 weeks to see their progress and monitoring
Other Name: HBPM

No Intervention: Control Group
Usual Care of hypertension in primary care clinic



Primary Outcome Measures :
  1. Change in Clinic Blood Pressure [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Proportion of subjects with normal body mass index [ Time Frame: 6 months ]
    We expect there will be increase in the percentage of subjects with normal body mass index (use the asian pacific population range (≥18.50 - <23)

  2. Reduction of fasting blood sugar level [ Time Frame: 6 months ]
    Change of lifestyle because of group education and home BP monitoring may reduce subject's body weight, therefore decrease level of fasting blood sugar

  3. Reduction of low density lipoprotein level (LDL) [ Time Frame: 6 months ]
    Change of lifestyle because of group education and home BP monitoring may change in diet, therefore decrease level of LDL

  4. Reduction in Average Systolic blood pressure record at home in 6 months when compare with the 1st month reading [ Time Frame: 1 monrth, 6 months ]
  5. Reduction in Average diastolic blood pressure record at home in 6 months when compare with the 1st month reading [ Time Frame: 1month, 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥65 years old
  2. Chinese
  3. on hypertensive treatment more than 12 months
  4. uncontrolled hypertension by mean clinic BP measurement on the day of recruitment. Uncontrolled hypertension is defined as BP > 140/90mmHg in subjects age < 80; and BP > 150/90mmHg in subjects age≥80.
  5. willing and capable to perform home BP monitoring by themselves on daily basis. -

Exclusion Criteria:

  1. unable to perform the home monitoring either by themselves
  2. mentally incapacitated
  3. arrhythmias
  4. unstable angina
  5. serum creatinine > 250 mmol/l
  6. orthostatic hypotension
  7. severe left ventricular impairment
  8. severe aortic stenosis
  9. pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551393


Contacts
Layout table for location contacts
Contact: Sau Nga FU, MBBS +852 36515409 h9317811@hku.hk

Sponsors and Collaborators
The University of Hong Kong
Hospital Authority, Hong Kong
Investigators
Layout table for investigator information
Principal Investigator: Sau Nga FU, MBBS Kwoloon West Cluster, Hospital Authority
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dr. Sau-nga Fu, Ph D Student, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02551393    
Other Study ID Numbers: KW/EX-15-115(88-14)
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: September 16, 2015
Last Verified: September 2015
Keywords provided by Dr. Sau-nga Fu, The University of Hong Kong:
Older adults
Home Blood Pressure Monitoring
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases