UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038029 |
|---|---|
| Receipt number | R000043357 |
| Scientific Title | Community mHealth Integrated Care (ComHIC) to manage hypertension/diabetes in Tanzania's overburdened health system |
| Date of disclosure of the study information | 2019/09/18 |
| Last modified on | 2024/03/21 10:23:16 |
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Basic information
Public title
Community mHealth Integrated Care (ComHIC) to manage hypertension/diabetes in Tanzania's overburdened health system
Acronym
Community mHealth Integrated Care (ComHIC) to manage hypertension/diabetes in Tanzania's overburdened health system
Scientific Title
Community mHealth Integrated Care (ComHIC) to manage hypertension/diabetes in Tanzania's overburdened health system
Scientific Title:Acronym
ComHIC implementation science study in Tanzania
Region
| Africa |
Condition
Condition
Hypertension and diabetes mellitus
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To apply mHealth in NCD programs using community health promoters. Community health promoters will apply mHealth to support existing local health systems to help control and manage Hypertension (HT) and Diabetes mellitus (DM) patients.
Basic objectives2
Others
Basic objectives -Others
(1) to assess capacity of local health system for management of HT/DM patients, (2) to elucidate impacts of introduction of mHealth with support of community health promoters for management of HT/DM patients, and (3) to develop strategies to improve management of HT/DM patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
systolic and diastolic blood pressure
(6, 12, 24 months from the start of intervention)
Key secondary outcomes
adherence to medication
adherence to clinical visits
(6, 12, 24 months from the start of intervention)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
mHealth (text messaging) with support of community health promoters, usual care
Interventions/Control_2
mHealth (text messaging) with support of community health promoters
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Uncontrolled HT (SBP >=140mmHg and DBP >=90mmHg on at least two separate readings) or Type 2 DM (HbA1c >7%). Receiving care from participating health facilities. Owns a mobile phone and have a voluntary family member who also owns a mobile phone.
Key exclusion criteria
Severely ill patients, any patient with complications related with HT and/or DM, type 1 DM, pregnant women, less than 18 years, and mentally ill patients.
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Nakamura |
Organization
Tokyo Medical and Dental University
Division name
Department of Global Health Entrepreneurship
Zip code
113-8519
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL
+81358034048
nakamura.ith@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Nakamura |
Organization
Tokyo Medical and Dental University
Division name
Department of Global Health Entrepreneurship
Zip code
113-8519
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL
+81358034048
Homepage URL
nakamura.ith@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The University of Dodoma, Tanzania
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
Yushima 1-5-45, Bunkyo-ku
Tel
+81-3-5803-5096
syomu1.adm@tmd.ac.jp
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
| 2019 | Year | 09 | Month | 18 | 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
909
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
| 2019 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043357
| 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 |
