Hypertension Treatment Adherence Improving Trial
Primary Purpose
Hypertension,Essential
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Educational program for hypertensive patients
Usual care
Sponsored by
About this trial
This is an interventional other trial for Hypertension,Essential focused on measuring hypertension, adherence, self-efficacy, educational intervention
Eligibility Criteria
Inclusion Criteria:
- Own a mobile phone and able to use
- Able to communicate with Cantonese and read Chinese
- Diagnosed with hypertension and taking at least one anti-hypertensive medication
- SBP = 131~159 mmHg or DBP = 81~99 mmHg
Exclusion Criteria:
- Renal hypertension
- Mini-Cog < 3
Sites / Locations
- Community Health Centres
- Complexo de Apoio à Família e de Serviço Comunitário de Seac Pai Van da União Geral das Associações dos Moradores de MacauRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
Participants will receive the newly developed theory-guided program for 12 weeks.
Participants will receive the usual care and non-hypertension related text messaging for 12 weeks.
Outcomes
Primary Outcome Measures
Change of blood pressure at week 8 and week 12
Systolic and diastolic blood pressure (mmHg) is measured by a trained research assistant. A validated upper-arm blood pressure monitor is used for the blood pressure measurement.
Secondary Outcome Measures
Change of Treatment Adherence Questionnaire for Patients with Hypertension (TAQPH) at week 8 and week 12
TAQPH consists of 28 items and covers the adherence to medications and lifestyle modifications in hypertension management. The responses are made on a 1-4 scale, and the sum of the score ranges from 28 to 112. The TAQPH has been proved to be reliable with good Cronbach's alpha coefficient 0.86 for Chinese hypertensive adults.
Change of Self-efficacy for managing chronic disease (SEMCD) at week 8 and week 12
SEMCD consists of six self-report items to measure the self-efficacy of hypertension management. Summative scores range from 6 to 60. The scale was translated into Chinese and yielded a good reliability (Cronbach's alpha = 0.88-0.98; teste-retest reliability = 0.73-0.98) in Chinese hypertensive adults and Chinese older adults.
Full Information
NCT ID
NCT04565548
First Posted
September 10, 2020
Last Updated
August 2, 2021
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT04565548
Brief Title
Hypertension Treatment Adherence Improving Trial
Official Title
Effect of an Educational Program for Hypertensive Patients: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 6, 2021 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Persistent adherence to lifestyle modifications and blood pressure lowering medications were the best way to control blood pressure. But low adherence was noted in reviews and studies resulting those taking blood pressure lowering medications could not achieve a controlled blood pressure. In this study, a theory-guided educational program will be developed with an aim to improve the blood pressure, self-efficacy and adherence behaviors among those diagnosed with high blood pressure in the community. 148 participants will be recruited and divided into control group and intervention group randomly in a ratio of 1:1. The intervention group will receive the theory-guided educational program, while the control group will receive the usual care. The study will last for 12 weeks. Data will be collected at baseline, week 8 and week 12. SPSS and generalized estimating equations model will be employed for data analysis. The results will inform an effective way to conduct health promotion in community. The improved adherence to lifestyle modifications and medications will be beneficial to the clients' health.
Detailed Description
Persistent adherence to lifestyle modifications and anti-hypertensive medications were emphasized in hypertension guidelines to control blood pressure effectively. But low adherence to lifestyle modifications and medication were noted in reviews and studies. Low adherence would lead to those received hypertension treatment did not achieve a controlled blood pressure. In this study, an educational program guided by the Health Promotion Model will be conducted to examine the effect on blood pressure, self-efficacy and treatment adherence among hypertensive patients in the community. A 2-arm parallel randomized control trial will be conducted. 148 participants will be recruited and divided into control and intervention group in a ration of 1:1. The intervention group will receive the theory-guided educational program, while the control group will receive the usual care. The study will last for 12 weeks. Data will be collected at baseline, week 8 and week 12. SPSS and generalized estimating equations model will be employed for data analysis. The results will inform community healthcare professionals about the effective way for health promotion, to enhance the adherence to lifestyle modifications and medications among hypertensive clients resulting sustainable benefits to the clients' health.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension,Essential
Keywords
hypertension, adherence, self-efficacy, educational intervention
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcomes assessors will not participate in group allocation or intervention delivery.
Allocation
Randomized
Enrollment
148 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will receive the newly developed theory-guided program for 12 weeks.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants will receive the usual care and non-hypertension related text messaging for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Educational program for hypertensive patients
Intervention Description
The theory-guided program consisted of one session of health education, self-developed leaflet, and weekly text messaging for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
One standardized health education and a leaflet developed by the Health Bureau. As similar as the intervention group, weekly text messaging will be delivered, but the content is not related to the blood pressure control.
Primary Outcome Measure Information:
Title
Change of blood pressure at week 8 and week 12
Description
Systolic and diastolic blood pressure (mmHg) is measured by a trained research assistant. A validated upper-arm blood pressure monitor is used for the blood pressure measurement.
Time Frame
Baseline, week 8, week 12
Secondary Outcome Measure Information:
Title
Change of Treatment Adherence Questionnaire for Patients with Hypertension (TAQPH) at week 8 and week 12
Description
TAQPH consists of 28 items and covers the adherence to medications and lifestyle modifications in hypertension management. The responses are made on a 1-4 scale, and the sum of the score ranges from 28 to 112. The TAQPH has been proved to be reliable with good Cronbach's alpha coefficient 0.86 for Chinese hypertensive adults.
Time Frame
Baseline, week 8, week 12
Title
Change of Self-efficacy for managing chronic disease (SEMCD) at week 8 and week 12
Description
SEMCD consists of six self-report items to measure the self-efficacy of hypertension management. Summative scores range from 6 to 60. The scale was translated into Chinese and yielded a good reliability (Cronbach's alpha = 0.88-0.98; teste-retest reliability = 0.73-0.98) in Chinese hypertensive adults and Chinese older adults.
Time Frame
Baseline, week 8, week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Own a mobile phone and able to use
Able to communicate with Cantonese and read Chinese
Diagnosed with hypertension and taking at least one anti-hypertensive medication
SBP = 131~159 mmHg or DBP = 81~99 mmHg
Exclusion Criteria:
Renal hypertension
Mini-Cog < 3
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hon Lon Tam, MSc
Phone
(852) 3400 3804
Email
hon-lon.tam@connect.polyu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Eliza Mi Ling Wong, Dr
Phone
(852) 2766 6544
Email
eliza.wong@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliza Mi Ling Wong, Dr
Organizational Affiliation
Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Health Centres
City
Shenzhen
State/Province
Shenzhen
ZIP/Postal Code
00
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qun Wang, PhD
Phone
53431457
Email
wangqunxing0204@163.com
Facility Name
Complexo de Apoio à Família e de Serviço Comunitário de Seac Pai Van da União Geral das Associações dos Moradores de Macau
City
Kowloon
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raven Lee
12. IPD Sharing Statement
Plan to Share IPD
No
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Hypertension Treatment Adherence Improving Trial
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