A Nurse-led Smartphone-based Self-management Programme for Type 2 Diabetes Patients With Poor Blood Glucose Control
A Randomised Controlled Trial on a Nurse-led Smartphone-based Self-management Programme for Type 2 Diabetes Patients With Poor Glycaemic Control
1 other identifier
interventional
128
0 countries
N/A
Brief Summary
Aim. To develop and compare a nurse-led smartphone-based self-management programme with an existing nurse-led diabetes service on health-related outcomes of type 2 diabetes patients with poor glycaemic control in Singapore. Background. Over the past decades, Asia has emerged as the 'diabetes epicentre' in the world due to rapid economic development, urbanisation, and nutrition transition. There is an urgent need to develop more effective care management strategies in response to this rising diabetes epidemic. Design. A randomised controlled trial with pre- and repeated post-tests control group design. Methodology. A total of 128 type 2 diabetes patients with poor glycaemic control will be recruited from the diabetes clinic of a public acute hospital in Singapore through convenience sampling. Study participants will be randomly allocated either to the experimental group or the control group. Outcome measures will include the 10-item General Self-Efficacy Scale, 11-item Revised Summary of Diabetes Self-care Activities, and 19-item Diabetes-Dependent Quality of Life. Data will be collected at three time points: baseline, 3 months, and 6 months from the baseline. Discussion. It is expected that this programme will be an alternative offered to diabetes patients to master their self-care management skills, in addition to the existing diabetes service provided in diabetes clinics in Singapore hospitals. Furthermore, the self-supporting and less resource-intensive nature of this programme, through the use of a smartphone application as the mode of intervention delivery, will greatly reduce nurses' direct contact time with patients and allow more time to be allocated to those who require more attention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2018
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2017
CompletedFirst Posted
Study publicly available on registry
March 23, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedMarch 23, 2017
March 1, 2017
1.5 years
March 13, 2017
March 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Self-efficacy: change is being assessed
Self-efficacy will be assessed using the General Self-efficacy Scale (GSS), a 10-item questionnaire of the unidimensional measure of one's competence to deal with the challenging events encountered in various life situations
Change from baseline self-efficacy at 6 months
Secondary Outcomes (9)
Diabetes self-care activities: change is being assessed
Change from baseline diabetes self-care acitivities at 6 months
Health-related Quality of Life: change is being assessed
Change from baseline health-related quality of life at 6 months
Acute Diabetes Complications: change is being assessed
Change from baseline acute diabetes complications at 6 months
HbA1c: change is being assessed
Change from baseline HbA1c at 6 months
Smoking status: change is being assessed
Change from baseline smoking status at 6 months
- +4 more secondary outcomes
Study Arms (2)
Experimental Group
EXPERIMENTALA six-month nurse-led smartphone-based self-management programme (i.e. NSSMP) will be provided to the participants in the experimental group.
Control Group
ACTIVE COMPARATORthe patients in the control group will receive the exiting nurse-led diabetes service (i.e. NDS) provided by the hospital
Interventions
The participants in the experimental group will undergo nurse-led smartphone-based self-management programme (NSSMP), a 6-month programme comprising an individual education session, and a newly developed smartphone App as a self-help education resource
the patients in the control group will receive the exiting nurse-led diabetes service (i.e. NDS) provided by the hospital
Eligibility Criteria
You may qualify if:
- have confirmed medical diagnosis of type 2 DM;
- are 21 years old and above;
- have blood test result of HbA1c \> 8% in the most recent test indicating poor glycemic control;
- possess and able to use smart mobile phone (e.g. Samsung Galaxy, iPhone) in their daily lives; and
- are able to speak and read English or Chinese.
You may not qualify if:
- have suffered severe complications such as severe stroke, visual impairment, renal failure that interfere with self-care activities;
- have known history of major psychiatric illness;
- have reading and hearing difficulties.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Jiang Y, Ramachandran HJ, Teo JYC, Leong FL, Lim ST, Nguyen HD, Wang W. Effectiveness of a nurse-led smartphone-based self-management programme for people with poorly controlled type 2 diabetes: A randomized controlled trial. J Adv Nurs. 2022 Apr;78(4):1154-1165. doi: 10.1111/jan.15178. Epub 2022 Feb 15.
PMID: 35170786DERIVEDWang W, Seah B, Jiang Y, Lopez V, Tan C, Lim ST, Ren H, Khoo YH. A randomized controlled trial on a nurse-led smartphone-based self-management programme for people with poorly controlled type 2 diabetes: A study protocol. J Adv Nurs. 2018 Jan;74(1):190-200. doi: 10.1111/jan.13394. Epub 2017 Aug 17.
PMID: 28727183DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Wenru P Wang, PhD
National University of Singapore
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 13, 2017
First Posted
March 23, 2017
Study Start
January 1, 2018
Primary Completion
June 30, 2019
Study Completion
December 30, 2019
Last Updated
March 23, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share