UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021613 |
|---|---|
| Receipt number | 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 21:50:26 |
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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
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
nkj0809@163.com
Sponsor or person
Institute
Tianjin Medical University,Nutrition and epidemiology institution
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024907
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
