PMID- 31779678
OWN - NLM
STAT- MEDLINE
DCOM- 20200608
LR  - 20240329
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 20
IP  - 1
DP  - 2019 Nov 28
TI  - TRIal to slow the Progression Of Diabetes (TRIPOD): study protocol for a 
      randomized controlled trial using wireless technology and incentives.
PG  - 650
LID - 10.1186/s13063-019-3749-x [doi]
LID - 650
AB  - BACKGROUND: The outcomes for those with type 2 diabetes mellitus (T2DM) in 
      Singapore are poor. In this TRIal to slow the Progression Of Diabetes (TRIPOD), 
      we will evaluate the effectiveness and cost-effectiveness of a comprehensive 
      diabetes management package (DMP), with or without a financial incentives 
      program, M-POWER Rewards, in efforts to improve HbA(1c) levels for individuals 
      with T2DM. METHODS/DESIGN: TRIPOD is a randomized, open-label, controlled, 
      multi-center, superiority trial with three parallel arms: (1) usual care only, 
      (2) usual care with DMP, and (3) usual care with DMP plus M-POWER Rewards. A 
      total of 339 adults with sub-optimally controlled T2DM (self-reported HbA(1c) 
      7.5-11.0%) will be block randomized according to a 1:1:1 allocation ratio to the 
      three arms. The primary outcome is mean change in HbA(1c) level at Month 12 from 
      baseline. Secondary outcomes include mean change in HbA(1c) level at Months 6, 
      18, and 24; mean changes at Months 6, 12, 18, and 24 in weight, blood pressure, 
      and self-reported physical activity, weight monitoring, blood glucose monitoring, 
      medication adherence, diabetes self-management, sleep quality, work productivity 
      and daily activity impairment, and health utility index; and proportion of 
      participants initiating insulin treatment by Months 6, 12, 18, and 24. 
      Incremental cost-effectiveness ratios will be computed based on costs per 
      improvement in HbA(1c) at Month 12 and converted to cost per quality-adjusted 
      life year gained. DISCUSSION: The TRIPOD study will present insights about the 
      long-term cost-effectiveness and financial viability of the interventions and the 
      potential for integrating within usual care. TRIAL REGISTRATION: 
      ClinicalTrials.gov, NCT03800680. Registered on 11 January 2019.
FAU - Lim, Robyn Su May
AU  - Lim RSM
AD  - Health Services & Systems Research, Duke-NUS Medical School, 8 College Road, 
      Singapore, 169857, Singapore.
FAU - Gardner, Daphne Su Lyn
AU  - Gardner DSL
AD  - Department of Endocrinology, Singapore General Hospital, Outram Road, Singapore, 
      169608, Singapore.
FAU - Bee, Yong Mong
AU  - Bee YM
AD  - Department of Endocrinology, Singapore General Hospital, Outram Road, Singapore, 
      169608, Singapore.
FAU - Cheung, Yin Bun
AU  - Cheung YB
AD  - Health Services & Systems Research, Duke-NUS Medical School, 8 College Road, 
      Singapore, 169857, Singapore.
AD  - Centre for Quantitative Medicine, Duke-NUS Medical School, 8 College Road, 
      Singapore, 169857, Singapore.
FAU - Bairavi, Joann
AU  - Bairavi J
AD  - Health Services & Systems Research, Duke-NUS Medical School, 8 College Road, 
      Singapore, 169857, Singapore.
FAU - Gandhi, Mihir
AU  - Gandhi M
AD  - Centre for Quantitative Medicine, Duke-NUS Medical School, 8 College Road, 
      Singapore, 169857, Singapore.
AD  - Department of Biostatistics, Singapore Clinical Research Institute, 31 Biopolis 
      Way, Singapore, 138669, Singapore.
FAU - Goh, Su-Yen
AU  - Goh SY
AD  - Department of Endocrinology, Singapore General Hospital, Outram Road, Singapore, 
      169608, Singapore.
FAU - Ho, Emily Tse Lin
AU  - Ho ETL
AD  - Department of Endocrinology, Singapore General Hospital, Outram Road, Singapore, 
      169608, Singapore.
FAU - Lin, Xinyi
AU  - Lin X
AD  - Centre for Quantitative Medicine, Duke-NUS Medical School, 8 College Road, 
      Singapore, 169857, Singapore.
AD  - Singapore Institute for Clinical Sciences, A*STAR, 30 Medical Drive, Singapore, 
      117609, Singapore.
FAU - Tan, Ngiap Chuan
AU  - Tan NC
AD  - Department of Research, SingHealth Polyclinics, 167 Jalan Bukit Merah, Singapore, 
      150167, Singapore.
FAU - Tay, Tunn Lin
AU  - Tay TL
AD  - Department of Endocrinology, Changi General Hospital, 2 Simei Street 3, 
      Singapore, 529889, Singapore.
FAU - Finkelstein, Eric Andrew
AU  - Finkelstein EA
AUID- ORCID: 0000-0001-6443-9686
AD  - Health Services & Systems Research, Duke-NUS Medical School, 8 College Road, 
      Singapore, 169857, Singapore. eric.finkelstein@duke-nus.edu.sg.
LA  - eng
SI  - ClinicalTrials.gov/NCT03800680
GR  - NMRC/HSRG/0079/2017/National Medical Research Council/
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20191128
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 0 (Glycated Hemoglobin)
RN  - 0 (hemoglobin A1c protein, human)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Humans
MH  - Middle Aged
MH  - Cost-Benefit Analysis
MH  - *Diabetes Mellitus, Type 2/blood/therapy
MH  - Disease Progression
MH  - Glycated Hemoglobin/analysis
MH  - *Motivation
MH  - Outcome Assessment, Health Care
MH  - Randomized Controlled Trials as Topic
MH  - Research Design
MH  - *Wireless Technology
MH  - Multicenter Studies as Topic
PMC - PMC6883710
OTO - NOTNLM
OT  - Behavior change
OT  - Blood glucose monitoring
OT  - Diabetes
OT  - Financial incentive
OT  - Medication adherence
OT  - Physical activity
OT  - Smartphone apps
OT  - Weight monitoring
OT  - mHealth
COIS- The authors declare that they have no competing interests.
EDAT- 2019/11/30 06:00
MHDA- 2020/06/09 06:00
PMCR- 2019/11/28
CRDT- 2019/11/30 06:00
PHST- 2019/08/04 00:00 [received]
PHST- 2019/09/23 00:00 [accepted]
PHST- 2019/11/30 06:00 [entrez]
PHST- 2019/11/30 06:00 [pubmed]
PHST- 2020/06/09 06:00 [medline]
PHST- 2019/11/28 00:00 [pmc-release]
AID - 10.1186/s13063-019-3749-x [pii]
AID - 3749 [pii]
AID - 10.1186/s13063-019-3749-x [doi]
PST - epublish
SO  - Trials. 2019 Nov 28;20(1):650. doi: 10.1186/s13063-019-3749-x.