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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021613
Receipt No. R000024907
Scientific Title Effects of a combined pedometer and home blood pressure monitoring program on blood pressure control in community-dwelling elderly adults with hypertension and diabetes
Date of disclosure of the study information 2016/03/25
Last modified on 2018/09/17

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Basic information
Public title Effects of a combined pedometer and home blood pressure monitoring program on blood pressure control in community-dwelling elderly adults with hypertension and diabetes
Acronym prevente and manage chronic diseases
Scientific Title Effects of a combined pedometer and home blood pressure monitoring program on blood pressure control in community-dwelling elderly adults with hypertension and diabetes
Scientific Title:Acronym prevente and manage chronic diseases
Region
Asia(except Japan)

Condition
Condition Chronic diseases
Classification by specialty
Cardiology Endocrinology and Metabolism Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine whether a combined pedometer and home blood pressure monitoring (HBPM) program could improve blood pressure (BP) status among community-dwelling older adults with hypertension and diabetes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The differences in mean blood pressure changes.
Key secondary outcomes The proportion of patients with controlled hypertension, intensification (titration and/or addition) of antihypertensive medications.

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 health education (lifestyles including diet and physical activity etc., once every two weeks, 3-5 minutes every time)
Interventions/Control_2 health education plus home blood pressure monitoring (twice a day, every morning and night)
Interventions/Control_3 health education plus the usage of pedometer (real time data everyday)
Interventions/Control_4 health education plus home blood pressure monitoring and the usage of pedometer
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
60 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria (1)Male and female over 60 years old;
(2)community residents with both hypertension and diabetes.
Key exclusion criteria (1)participants who declined to participate;
(2)participants who unable to complete intervention and examination over 12 months;
(3)participants who used pedometer and/or home blood pressure monitoring (measured blood pressure >=twice a day) before;
(4)participants who had severe diseases which limited activity such as cancer, severe depression, disability, heart attack or stroke within the previous 6 months, severe pulmonary disease, acute arthritis etc.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Niu Kaijun
Organization Tianjin Medical University
Division name Nutrition and epidemiology institution
Zip code
Address 22 Qixiangtai Road, Heping District, Tianjin, P.R.China.
TEL +86(0)22-83336613
Email nkj0809@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Bao Xue and Gu Yeqing
Organization Tianjin Medical University
Division name Nutrition and epidemiology institution
Zip code
Address 22 Qixiangtai Road, Heping District, Tianjin, P.R.China.
TEL +86(0)22-83336613
Homepage URL
Email nkj0809@163.com

Sponsor
Institute Tianjin Medical University,Nutrition and epidemiology institution
Institute
Department

Funding Source
Organization Financial support from science and technology planning program of Beichen District, Tianjin.
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 25 Day
Last modified on
2018 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024907

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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