Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD): Protocol for a Clinical Nonrandomized Pilot Trial in Brunei Darussalam
BackgroundThe prevalence of type 2 diabetes mellitus (T2DM) is increasing worldwide. Digital interventions that incorporate the use of mobile phones and wearables have been getting popular. A combination of a digital intervention with support from professional management can...
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| Format: | Article |
| Language: | English |
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JMIR Publications
2022-12-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2022/12/e43208 |
| _version_ | 1797734485645590528 |
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| author | Hiu Nam Chan Hong Shen Lim Pui Lin Chong Chee Kwang Yung Musjarena Abd Mulok Yuan Wei Alice Moi Ling Yong |
| author_facet | Hiu Nam Chan Hong Shen Lim Pui Lin Chong Chee Kwang Yung Musjarena Abd Mulok Yuan Wei Alice Moi Ling Yong |
| author_sort | Hiu Nam Chan |
| collection | DOAJ |
| description |
BackgroundThe prevalence of type 2 diabetes mellitus (T2DM) is increasing worldwide. Digital interventions that incorporate the use of mobile phones and wearables have been getting popular. A combination of a digital intervention with support from professional management can enhance users’ self-efficacy better than a digital intervention alone and provide better accessibility to a lifestyle intervention. However, there are limited studies exploring the feasibility and efficacy of applying a digital intervention in Muslim-majority countries, and none have been conducted in Brunei Darussalam.
ObjectiveThe study aims to determine the effectiveness and feasibility of a proposed 16-week digital intervention program for T2DM self-management and to guide the rollout of a mobile app as part of a population health solution for adults with T2DM in Brunei. The primary outcome of this study is to measure the proportion of participants with a hemoglobin A1c (HbA1c) reduction of at least 0.6% from baseline, and the secondary outcomes include a change in HbA1c, BMI, lipid profile, and EQ-5D-5L score.
MethodsThis single-arm nonrandomized pilot study will recruit participants using web-based (with the national health care app [BruHealth] and official social media platforms being used for outreach) and offline (in-person recruitment at health centers) approaches. A target of 180 individuals with T2DM aged between 20 and 70 years that meet the inclusion criteria will be enrolled in a 16-week digital intervention program. Baseline and postintervention markers will be evaluated.
ResultsThe study received approval from the Medical and Health Research & Ethics Committee of the Brunei Darussalam Ministry of Health (MHREC/MOH/2022/4(1)). The recruitment process is ongoing, and we anticipate that the study will conclude by April 2023. This will be followed by data analysis and the reporting of outcomes with the intention to publish. The results of this study will be disseminated through scientific publications and conferences. This study will serve as a guide to launch T2DM digital therapeutic programs and extend to other noncommunicable diseases (NCDs) if proven as an effective and feasible approach in Brunei.
ConclusionsThe Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD) study will be the first study to investigate the clinical effectiveness and feasibility of the proposed 16-week T2DM digital intervention program tailored for Brunei, a Muslim-majority country. The findings of this study can potentially scale up the proposed model of care to other NCDs as a national approach for health management solutions.
Trial RegistrationClinicalTrials.gov NCT05364476; https://clinicaltrials.gov/ct2/show/NCT05364476
International Registered Report Identifier (IRRID)DERR1-10.2196/43208 |
| first_indexed | 2024-03-12T12:45:04Z |
| format | Article |
| id | doaj.art-11a9796b81f1406a8fb2cab5ad4f8d5c |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-03-12T12:45:04Z |
| publishDate | 2022-12-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-11a9796b81f1406a8fb2cab5ad4f8d5c2023-08-28T23:24:13ZengJMIR PublicationsJMIR Research Protocols1929-07482022-12-011112e4320810.2196/43208Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD): Protocol for a Clinical Nonrandomized Pilot Trial in Brunei DarussalamHiu Nam Chanhttps://orcid.org/0000-0003-4479-7288Hong Shen Limhttps://orcid.org/0000-0002-7809-3492Pui Lin Chonghttps://orcid.org/0000-0002-7747-4162Chee Kwang Yunghttps://orcid.org/0000-0002-8023-5357Musjarena Abd Mulokhttps://orcid.org/0000-0002-5395-0005Yuan Weihttps://orcid.org/0000-0001-7550-5052Alice Moi Ling Yonghttps://orcid.org/0000-0003-4088-5619 BackgroundThe prevalence of type 2 diabetes mellitus (T2DM) is increasing worldwide. Digital interventions that incorporate the use of mobile phones and wearables have been getting popular. A combination of a digital intervention with support from professional management can enhance users’ self-efficacy better than a digital intervention alone and provide better accessibility to a lifestyle intervention. However, there are limited studies exploring the feasibility and efficacy of applying a digital intervention in Muslim-majority countries, and none have been conducted in Brunei Darussalam. ObjectiveThe study aims to determine the effectiveness and feasibility of a proposed 16-week digital intervention program for T2DM self-management and to guide the rollout of a mobile app as part of a population health solution for adults with T2DM in Brunei. The primary outcome of this study is to measure the proportion of participants with a hemoglobin A1c (HbA1c) reduction of at least 0.6% from baseline, and the secondary outcomes include a change in HbA1c, BMI, lipid profile, and EQ-5D-5L score. MethodsThis single-arm nonrandomized pilot study will recruit participants using web-based (with the national health care app [BruHealth] and official social media platforms being used for outreach) and offline (in-person recruitment at health centers) approaches. A target of 180 individuals with T2DM aged between 20 and 70 years that meet the inclusion criteria will be enrolled in a 16-week digital intervention program. Baseline and postintervention markers will be evaluated. ResultsThe study received approval from the Medical and Health Research & Ethics Committee of the Brunei Darussalam Ministry of Health (MHREC/MOH/2022/4(1)). The recruitment process is ongoing, and we anticipate that the study will conclude by April 2023. This will be followed by data analysis and the reporting of outcomes with the intention to publish. The results of this study will be disseminated through scientific publications and conferences. This study will serve as a guide to launch T2DM digital therapeutic programs and extend to other noncommunicable diseases (NCDs) if proven as an effective and feasible approach in Brunei. ConclusionsThe Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD) study will be the first study to investigate the clinical effectiveness and feasibility of the proposed 16-week T2DM digital intervention program tailored for Brunei, a Muslim-majority country. The findings of this study can potentially scale up the proposed model of care to other NCDs as a national approach for health management solutions. Trial RegistrationClinicalTrials.gov NCT05364476; https://clinicaltrials.gov/ct2/show/NCT05364476 International Registered Report Identifier (IRRID)DERR1-10.2196/43208https://www.researchprotocols.org/2022/12/e43208 |
| spellingShingle | Hiu Nam Chan Hong Shen Lim Pui Lin Chong Chee Kwang Yung Musjarena Abd Mulok Yuan Wei Alice Moi Ling Yong Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD): Protocol for a Clinical Nonrandomized Pilot Trial in Brunei Darussalam JMIR Research Protocols |
| title | Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD): Protocol for a Clinical Nonrandomized Pilot Trial in Brunei Darussalam |
| title_full | Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD): Protocol for a Clinical Nonrandomized Pilot Trial in Brunei Darussalam |
| title_fullStr | Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD): Protocol for a Clinical Nonrandomized Pilot Trial in Brunei Darussalam |
| title_full_unstemmed | Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD): Protocol for a Clinical Nonrandomized Pilot Trial in Brunei Darussalam |
| title_short | Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD): Protocol for a Clinical Nonrandomized Pilot Trial in Brunei Darussalam |
| title_sort | development and exploration of the effectiveness and feasibility of a digital intervention for type 2 diabetes mellitus desired protocol for a clinical nonrandomized pilot trial in brunei darussalam |
| url | https://www.researchprotocols.org/2022/12/e43208 |
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