Precision Health Care Program on HbA1c and Diabetes Self-management

1. Background
Registration Number	INA-EXARW07
Date of registry approval	15-11-2023
Registration Date	15-06-2023
Secondary identifiers	No
Name of issuing authority (for example protocol number, other registries, etc)
Secondary identifier number
Scientific study title	Effectiveness of Precision Health Care Program on HbA1c and Diabetes Self-management in Indonesia: A Randomized Controlled Trial
Public (popular study title)	Precision Health Care Program on HbA1c and Diabetes Self-management
2. Sponsor and Funding
Primary Sponsor	Universitas Muhammadiyah Semarang
Source(s) of monetary or material support	Funding
Other partners
3. Contact details
Principal Investigator
Principal investigator	Satriya Pranata
City	Semarang
Country	Indonesia
Principal investigator's affiliation	Universitas Muhammadiyah Semarang
Principal Investigator's email address	satriya.pranata@unimus.ac.id
Public Queries
Contact person name for public queries	Satriya Pranata
Address for public queries	Kedungmundu street
City	Semarang
Country	Indonesia
ZIP	50273
Affiliation for public queries	Universitas Muhammadiyah Semarang
Email address for public queries	satriya.pranata@unimus.ac.id
Phone number for public queries	085333775366
Scientific Queries
Name of Contact for scientific queries	Yunie Armiyati
Address for scientific queries	Kedungmundu street
City	Semarang
Country	Indonesia
ZIP	50273
Affiliation of scientific queries contact	Universitas Muhammadiyah Semarang
Email address for scientific queries	satriya.pranata@unimus.ac.id
4. IRB & Regulatory
Ethical Approval number	0073/KEPK/XII/2021
Name of Ethics committee	HEALTH RESEARCH ETHICS COMMISSION FAKULTAS ILMU KEPERAWATAN DAN KESEHATAN UNIVERSITAS MUHAMMADIYAH SEMARANG FACULTY OF NURSING AND HEALTH SCIENCES UNIVERSITAS MUHAMMADIYAH SEMARANG
Date of Ethic approval	26-12-2020
Contact details of Ethic Committee (phone, email, and office)	Universitas Muhammadiyah Semarang
Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB)	Not applicable
5. Status
Countries of recruitment	Indonesia
Study sites in Indonesia	Sumbawa, West Nusa Tenggara
Recruitment status	Initial
Date of first enrollment	07-01-2021
Targeted Sample size	00163 -
Number of enrolled participants	163
Date of study completion (last participant, last visit)
6. Study Design & Purpose
Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error)	diabetes
Purpose of the study	Prevention
Study type	Interventional
Interventional Study category	Clinical trial
Study phase	Phase 3
Method of allocation	Randomized allocation
Description of the allocation concealment mechanism and sequence generation	Diabetes patients who attended and registered at the designated primary healthcare centers on Sumbawa Island were included in the study. In this investigation, simple randomization with computed random numbers was performed. Following randomization by researchers, each respondent received a unique informed consent. The intervention group was given informed consent to introduce tailored care, while the control group was given traditional health education informed consent. Figure 1 shows the recruitment process for this randomized control trial.
Masking	Yes (blinded), who is masked
Study intervention (study arm)	In this study, the strategies of tailored care for diabetes were divided into 7 steps: (1) Brief deducting teaching; (2) Assessment for self-management level; (3) Brainstorming among patients to share their difficulty on glycaemic target and specific target behaviour; (4) Making a list of patients’ needs then ranking the priorities; (5) Setting a goal and writing action; (6) Follow-up; and (7) Report of goals attempt. Following a brief deducting teaching, two research assistants were involved in delivering the support group and brainstorming. Table 1 shows the specifics tailored care strategies.
Control intervention (control arm)	Routine blood sugar monitoring, blood pressure tests, and monthly health counselling were standard services provided by primary health care facilities for each group Information regarding health education was provided through leaflets and posters by standard operating procedures from the primary health care centers in Sumbawa Island, Indonesia, where this study took place.
Intervention assignment	Single arm
7. Eligibility Criteria
Gender inclusion criteria	Not specified
Minimum age	older than 20
Maximum age	older than 20
Inclusion criteria	Patients with diabetes who were checked from their medical records, being older than 20 at the time of recruitment, identifying as Indonesian ethnic group, willing to trial participation, having a mobile device, and setting up residence with family were all required for inclusion in the study.
Exclusion criteria	Patients with ischemic heart disease, transient ischemic attack (TIA), peripheral vascular disease, or persistent mental health concerns were barred from participating.
8. Study Outcome
Primary Outcome
Name of primary outcome	This study aimed to assess how effectively a tailored care intervention program affected HbA1c and diabetes self-management among diabetes patients in Sumbawa Island, Indonesia.
Metric/method of measurement	HbA1c and the diabetes self-Management were measured twice: at M1 (baseline, before to the intervention), and M2 (3 months from commencement of the intervention). The HbA1c laboratory test and the Diabetes Self-Management Questionnaire (DSMQ) were the tools utilized to collect the data.
Timepoint(s) of measurement	three months
9. Study Results
Brief summary of study results
Date of results summaries
Participant flow
Baseline characteristic
Adverse events
Outcome measures
10. Publication
URL hyperlink(s) related to results and publications
IPD sharing statement (Statement regarding the intended sharing of deidentified individual clinical trial participant-level data (IPD))
Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses)
Other important informations