Effect of Smart Phone Based Telemonitoring on Blood Pressure Among Hypertensive Patients in Primary Care

NCT02046993 | Completed Results DMC

• 2 other identifiers: KW/EX-13-026(60-09)HKCFPRFG2013
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

To test the hypothesis that hypertensive patients who participate in smart phone based telemonitoring of BP will conduct more home blood pressure monitoring, better self management behavior and greater reduction in blood pressure and better self management behaviour from baseline to 6 months follow up than those patients receiving enhanced usual care.

Conditions

Hypertension; Blood Pressure

Keywords

Hypertension; self blood pressure monitoring; smartphone based telemonitoring; primary care

Outcome Measures

Primary Outcomes (5)

• Percentage of Subjects Doing Home BP Monitoring

  Percentage of subjects doing home BP monitoring with at least BP recordings of three or more times/week

  Baseline, 3rd month, 6th month

• Change in Mean Clinic Systolic and Diastolic Blood Pressure CSBP and CDBP Readings at 3 and 6 Months From Baseline

  At baseline and follow-up visits, research assistants who are blinded to allocation outcomes will meaure blood pressure after 15 minutes rest with validated electronic automated sphygmanometer ( ) . Four blood pressure readings taken at 1 minute interval will done for each subject and the mean of the second and third reading would be used for the primary outcome ,

  baseline, 3rd month and 6 month

• Comparison of Mean Home Systolic and Diastolic Blood Pressure mHSBP and mHDBP Readings Between Intervention and Control Grp at Baseline

  At baseline and follow-up visits, research assistants will collect the HSBP and HSBP readings of both groups at baseline, 3rd and 6th month FU. Regular home BP measurement is taken as the average of at least 3 or more BP measurement readings per week. The research assistant are not blinded and will collect the average of paper SBP and DBP measurement recordings ( if done) of the control group at baseline,at 3rd month and 6th month. The research assistant are not blinded and will collect the average of smartphone based SBP and DBP measurement recordings ( if done) and sent to the data center of the intervention group at baseline,at 3rd month and 6th month.

  baseline

• Comparison of Mean Home Systolic and Diastolic Blood Pressure mHSBP and mHDBP Readings at 3 Months Between Smart Phone Based Telemonitoring Group and Control Group on Enhanced Usual Care

  At baseline and follow-up visits, research assistants will collect the HSBP and HSBP readings of both groups at baseline, 3rd and 6th month FU. Regular home BP measurement is taken as the average of at least 3 or more BP measurement readings per week. The research assistant are not blinded and will collect the average of paper SBP and DBP measurement recordings ( if done) of the control group at baseline,at 3rd month and 6th month. The research assistant are not blinded and will collect the average of smartphone based SBP and DBP measurement recordings ( if done) and sent to the data center of the intervention group at baseline,at 3rd month and 6th month.

  3 months

• Comparison Between Mean Home Systolic and Diastolic Blood Pressure HSBP and HDBP Readings at 6 Months Between the Smartphone Based Telemonitoring Group and Control Group on Enhanced Usual Care

  At baseline and follow-up visits, research assistants will collect the HSBP and HSBP readings of both groups at baseline, 3rd and 6th month FU. Regular home BP measurement is taken as the average of at least 3 or more BP measurement readings per week. The research assistant are not blinded and will collect the average of paper SBP and DBP measurement recordings ( if done) of the control group at baseline,at 3rd month and 6th month. The research assistant are not blinded and will collect the average of smartphone based SBP and DBP measurement recordings ( if done) and sent to the data center of the intervention group at baseline,at 3rd month and 6th month.

  6 months

Secondary Outcomes (1)

• Self-efficacy for Managing Chronic Disease: 6 Items Scale (SEMCD-6 Items) Comparing Both Groups at 3 and 6 Months Post-intervention

  6 months

Study Arms (2)

Smart phone based telemonitoring of HBP

EXPERIMENTAL

1. . Patients do HBP monitoring 2. . record their BP readings into the smart phone with downloaded application.

Behavioral: Smart phone telemonitoring HBP + enhanced usual care; Behavioral: Enhanced usual care

Enhanced usual care

ACTIVE COMPARATOR

1. . Patients to do HBP measurement 2. . Record BP readings in their diary

Behavioral: Smart phone telemonitoring HBP + enhanced usual care; Behavioral: Enhanced usual care

Interventions

Smart phone telemonitoring HBP + enhanced usual care BEHAVIORAL

Smart phone telemonitoring home Blood pressure (HBP) Patients input their HBP readings to their smart phone which is sent to the data center regulary

Enhanced usual care; Smart phone based telemonitoring of HBP

Enhanced usual care BEHAVIORAL

Encouraged to do HBP measurement and record BP readings in paper diary

Enhanced usual care; Smart phone based telemonitoring of HBP

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All hypertensive patients aged 30 or above and using smart phone
• Agrees to participate in this pilot study
• required to attend structured HBPM education program and assessed competent in self BP measurement

You may not qualify if:

• Patients could not use the smart phone independently, such as mentally or physically incapacitated.
• Patients are not competent in verbal or written communication.

Sponsors & Collaborators

• Kwong Wah Hospital: lead

Study Sites (1)

Kwong Wah Hospital General Out-Patient and Family Medicine Department

Hong Kong, Kowloon, Hong Kong, Hong Kong

Location

Related Publications (1)

• Fung CS, Wong WC, Wong CK, Lee A, Lam CL. Home blood pressure monitoring--a trial on the effect of a structured education program. Aust Fam Physician. 2013 Apr;42(4):233-7.

  PMID: 23550251 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

The baseline mean Clinic SBP and DBP as well as the baseline mean home SBP and DBP of both the control and intervention group were already within the optimal range.

Results Point of Contact

• Title: Dr Lorna Ng
• Organization: Kwong Wah Hospital

ngl@ha.org.hk

(852) 23322311

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Medical Officer

Study Record Dates

• First Submitted: January 25, 2014
• First Posted: January 28, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: December 12, 2016
• Results First Posted: December 12, 2016

Record last verified: 2016-10

Locations

HK (1)