Diabetes MellitusCeHPNCT04560296
Community-based E-Health Program for Older Adults Living With Chronic Diseases
A study testing Community-based E-Health Program and usual self-management and follow up with doctors/nurse in people with Diabetes Mellitus and Hypertension, run by National University of Singapore at 9 sites in Singapore.
Trial summary
With increased aging population, there is a higher rate of having chronic diseases and cognitive impairment. In order to achieve successful aging, it is important for community-dwelling older adults to perform better self-management with improved health literacy and various kinds of support. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Hypertension, Hyperlipidemias
- What is being tested?
- Community-based E-Health Program and usual self-management and follow up with doctors/nurse
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 9 sitesSingapore
- Study dates
- 15 Sep 2020to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) aged 60 or above; 2) able to understand and communicate in either English or Mandarin; 3) able to give consent to participate; 4) lives within the community setting; 5) diagnosed with chronic conditions (Hypertension, Hyperlipidemia, and Diabetes Mellites); 6) able to commit to the research program throughout the whole duration.
Who cannot join
- severe cognitive impairment;
- severe psychiatric disorders;
- severe vision impairment;
- severe hearing impairment.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Singapore9 sites
Brahm Centre @ Tampines
Singapore, Singapore, 520473
THK SAC @ Bedok Radiance
Singapore, 460012
THK SAC @ Kaki Bukit
Singapore, 462509
Pap Community Foundation 3-in-1 Family Centre (Aged Care)
Singapore, 520209
Brahm Centre @ Simei 227
Singapore, 520227
Lb Sac @ 434 Tampines
Singapore, 520434
Presbyterian Community Services - Evergreen Circle Seniors Activity Centre
Singapore, 521827
Lb Sac @ 499C Tampines
Singapore, 523499
Lb Sac (Sa) @ Tampines 494E
Singapore, 525494
About this study
Official title: Community-based E-Health Program for Older Adults Living With Chronic Diseases - A Cluster Controlled Study With Process Evaluation
With increased aging population, there is a higher rate of having chronic diseases and cognitive impairment. In order to achieve successful aging, it is important for community-dwelling older adults to perform better self-management with improved health literacy and various kinds of support. The study aims to develop a Community-based E-Health Program (CeHP) for Older Adults Living with Chronic Diseases , evaluate the effectiveness of CeHP, and refine the program based on the outcome measurement. A cluster controlled trial will be adopted. A follow-up process evaluation will be conducted to assess the acceptability, strengths and limitations of CeHP based on the participants' perspectives. The research contributes to engage and empower older adults living in the community to manage their chronic condition, and foster collaboration with the goal of translating evidence into action.
Read the detailed description
Background:
With increased aging population, there is a higher rate of having chronic diseases and cognitive impairment. In order to achieve successful aging, it is important for community-dwelling older adults to perform better self-management with improved health literacy and various kinds of support.
Objectives:
The study aims to develop a Community-based E-Health Program (CeHP), evaluate the effectiveness of CeHP, and refine the program based on the outcome measurement.
Method:
The research team will develop the Community-based E-Health Program, and assess the effects of the program. A needs assessment will be carried out using focus group discussion with the older adults. A cluster controlled trial will be adopted. A follow-up process evaluation will be conducted to assess the acceptability, strengths and limitations of Community-based E-Health Program based on the participants' perspectives
Discussion and conclusion:
The proposed research contributes to engage and empower older adults living in the community to manage their chronic condition, and foster collaboration with the goal of translating evidence into action. This research will offer important insights into the need for educating and engaging older adults in managing chronic conditions to promote health and well-being, and therefore contribute to health and well-being of the elderly population.
- Conditions
- Diabetes Mellitus, Hypertension, Hyperlipidemias
- Being tested
- Community-based E-Health Program, usual self-management and follow up with doctors/nurse
- Keywords
- community-dwelling older adults, chronic diseases, self-management, e-health, cognitive impairment
- Medical subject headings
- Diabetes Mellitus, Hypertension, Hyperlipidemias, Chronic Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based E-Health ProgramBehavioural
Community-based E-Health Program will be developed to engage and empower older adults to manage the chronic conditions effectively.
usual self-management and follow up with doctors/nurseBehavioural
usual self-management and follow up with doctors/nurse as planned in the community nurse post.
| Study group | Role | What they receive |
|---|---|---|
| Community-based E-Health Program | Experimental | The intervention group will consist of 80 participants who will engage in Community-based E-Health Program. Receives: Behavioral: Community-based E-Health Program |
| usual self-management and follow up with doctors/nurse | Active comparator | The participants will receive the usual self-management and follow up with doctors/nurse as planned. Receives: Behavioral: usual self-management and follow up with doctors/nurse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-care ability of Chronic disease
Self-care of Chronic Illness Inventory
Measured: baseline, 3 month, 6 month
Secondary outcomes (11)
Change in Patient Empowerment
Patient Empowerment scale
Measured: baseline, 3 month, 6 month
Change in Health Literacy
Health Literacy Scale, minimum value is 12, maximum value is 48, higher scores mean a better outcome.
Measured: baseline, 3 month, 6 month
Change in Social support
Social support Questionnaire
Measured: baseline, 3 month, 6 month
Change in Healthy Aging practice
Healthy Aging Instrument
Measured: baseline, 3 month, 6 month
Montreal Cognitive Assessment
Singapore version 2010
Measured: baseline, 3 month, 6 month
Symbol Digit modality test
Quickly screens for organic cerebral dysfunction in both children and adults, patient substitutes a number, either orally or written, for randomized presentations of geometric figures
Measured: baseline, 3 month, 6 month
HbA1c
glycemic control
Measured: baseline, 3 month
Lipid panel
HDL, LDL, triglycerides
Measured: baseline, 3 month
Immunological profile
Cytokines (IL-1, IL6, IL15), TNFa, C1q, antinuclear antibody, antiDNA antibody
Measured: baseline, 3 month
Hormones
Cortisol, DHEA, insulin
Measured: baseline, 3 month
Fasting glucose
Plasma glucose concentration after fasting for 8 hours
Measured: baseline, 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start15 Sep 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cluster Controlled Study
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Changi General Hospital
- Responsible party
- Principal investigator, Vivien Xi WU, PhD, National University of Singapore
- Investigators
- Vivien Xi Wu, PhD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560296
- Sponsor's protocol ID
- NUHSRO/2019/081/Startup/06
- Acronym
- CeHP
- Status last verified
- Nov 2024
- First submitted
- 3 Sep 2020
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van der Heide I, Poureslami I, Mitic W, Shum J, Rootman I, FitzGerald JM. Health literacy in chronic disease management: a matter of interaction. J Clin Epidemiol. 2018 Oct;102:134-138. doi: 10.1016/j.jclinepi.2018.05.010. Epub 2018 May 21.
PubMed 29793001Vijayan M, Reddy PH. Stroke, Vascular Dementia, and Alzheimer's Disease: Molecular Links. J Alzheimers Dis. 2016 Sep 6;54(2):427-43. doi: 10.3233/JAD-160527.
PubMed 27567871Tan HH, Xu J, Teoh HL, Chan BP, Seet RC, Venketasubramanian N, Sharma VK, Chen CL, Dong Y. Decline in changing Montreal Cognitive Assessment (MoCA) scores is associated with post-stroke cognitive decline determined by a formal neuropsychological evaluation. PLoS One. 2017 Mar 27;12(3):e0173291. doi: 10.1371/journal.pone.0173291. eCollection 2017.
PubMed 28346532van de Bovenkamp HM, Dwarswaard J. The complexity of shaping self-management in daily practice. Health Expect. 2017 Oct;20(5):952-960. doi: 10.1111/hex.12536. Epub 2017 Feb 2.
PubMed 28152248Koetsenruijter J, van Eikelenboom N, van Lieshout J, Vassilev I, Lionis C, Todorova E, Portillo MC, Foss C, Serrano Gil M, Roukova P, Angelaki A, Mujika A, Knutsen IR, Rogers A, Wensing M. Social support and self-management capabilities in diabetes patients: An international observational study. Patient Educ Couns. 2016 Apr;99(4):638-643. doi: 10.1016/j.pec.2015.10.029. Epub 2015 Nov 2.
PubMed 26549171Beauchamp A, Peeters A, Tonkin A, Turrell G. Best practice for prevention and treatment of cardiovascular disease through an equity lens: a review. Eur J Cardiovasc Prev Rehabil. 2010 Oct;17(5):599-606. doi: 10.1097/HJR.0b013e328339cc99.
PubMed 20562629Solomon M, Wagner SL, Goes J. Effects of a Web-based intervention for adults with chronic conditions on patient activation: online randomized controlled trial. J Med Internet Res. 2012 Feb 21;14(1):e32. doi: 10.2196/jmir.1924.
PubMed 22353433Epidemiology & Disease Control Division, et al., The Burden of Disease in Singapore, 1990-2017: An overview of the Global Burden of Disease Study 2017results. 2019: Seattle, WA: IHME
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based E-Health Program for Older Adults Living With Chronic Diseases - A Cluster Controlled Study With Process Evaluation
- ClinicalTrials.gov ID
- NCT04560296
- Acronym / sponsor ID
- CeHP / NUHSRO/2019/081/Startup/06
- Conditions
- Diabetes Mellitus, Hypertension, Hyperlipidemias
- Keywords
- community-dwelling older adults, chronic diseases, self-management, e-health, cognitive impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Changi General Hospital
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With increased aging population, there is a higher rate of having chronic diseases and cognitive impairment. In order to achieve successful aging, it is important for community-dwelling older adults to perform better self-management with improved health literacy and various kinds of support. The study aims to develop a Community-based E-Health Program (CeHP) for Older Adults Living with Chronic Diseases , evaluate the effectiveness of CeHP, and refine the program based on the outcome measurement. A cluster controlled trial will be adopted. A follow-up process evaluation will be conducted to assess the acceptability, strengths and limitations of CeHP based on the participants' perspectives. The research contributes to engage and empower older adults living in the community to manage their chronic condition, and foster collaboration with the goal of translating evidence into action.
Detailed description
Background:
With increased aging population, there is a higher rate of having chronic diseases and cognitive impairment. In order to achieve successful aging, it is important for community-dwelling older adults to perform better self-management with improved health literacy and various kinds of support.
Objectives:
The study aims to develop a Community-based E-Health Program (CeHP), evaluate the effectiveness of CeHP, and refine the program based on the outcome measurement.
Method:
The research team will develop the Community-based E-Health Program, and assess the effects of the program. A needs assessment will be carried out using focus group discussion with the older adults. A cluster controlled trial will be adopted. A follow-up process evaluation will be conducted to assess the acceptability, strengths and limitations of Community-based E-Health Program based on the participants' perspectives
Discussion and conclusion:
The proposed research contributes to engage and empower older adults living in the community to manage their chronic condition, and foster collaboration with the goal of translating evidence into action. This research will offer important insights into the need for educating and engaging older adults in managing chronic conditions to promote health and well-being, and therefore contribute to health and well-being of the elderly population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Community-based E-Health Program | Experimental | Behavioral: Community-based E-Health ProgramThe intervention group will consist of 80 participants who will engage in Community-based E-Health Program. |
| usual self-management and follow up with doctors/nurse | Active comparator | Behavioral: usual self-management and follow up with doctors/nurseThe participants will receive the usual self-management and follow up with doctors/nurse as planned. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) aged 60 or above; 2) able to understand and communicate in either English or Mandarin; 3) able to give consent to participate; 4) lives within the community setting; 5) diagnosed with chronic conditions (Hypertension, Hyperlipidemia, and Diabetes Mellites); 6) able to commit to the research program throughout the whole duration.
Key exclusion criteria (4 listed)
- severe cognitive impairment;
- severe psychiatric disorders;
- severe vision impairment;
- severe hearing impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community-based E-Health ProgramCommunity-based E-Health Program will be developed to engage and empower older adults to manage the chronic conditions effectively. | Behavioural | Community-based E-Health Program |
| usual self-management and follow up with doctors/nurseusual self-management and follow up with doctors/nurse as planned in the community nurse post. | Behavioural | usual self-management and follow up with doctors/nurse |
Primary outcome
Change in Self-care ability of Chronic disease
Time frame: baseline, 3 month, 6 month
Self-care of Chronic Illness Inventory
11 secondary outcomes
Change in Patient Empowerment
Time frame: baseline, 3 month, 6 month
Change in Health Literacy
Time frame: baseline, 3 month, 6 month
Change in Social support
Time frame: baseline, 3 month, 6 month
Change in Healthy Aging practice
Time frame: baseline, 3 month, 6 month
Montreal Cognitive Assessment
Time frame: baseline, 3 month, 6 month
Symbol Digit modality test
Time frame: baseline, 3 month, 6 month
HbA1c
Time frame: baseline, 3 month
Lipid panel
Time frame: baseline, 3 month
Immunological profile
Time frame: baseline, 3 month
Hormones
Time frame: baseline, 3 month
Fasting glucose
Time frame: baseline, 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Background: PubMed 29793001van der Heide I, Poureslami I, Mitic W, Shum J, Rootman I, FitzGerald JM. Health literacy in chronic disease management: a matter of interaction. J Clin Epidemiol. 2018 Oct;102:134-138. doi: 10.1016/j.jclinepi.2018.05.010. Epub 2018 May 21.
- Background: PubMed 27567871Vijayan M, Reddy PH. Stroke, Vascular Dementia, and Alzheimer's Disease: Molecular Links. J Alzheimers Dis. 2016 Sep 6;54(2):427-43. doi: 10.3233/JAD-160527.
- Background: PubMed 28346532Tan HH, Xu J, Teoh HL, Chan BP, Seet RC, Venketasubramanian N, Sharma VK, Chen CL, Dong Y. Decline in changing Montreal Cognitive Assessment (MoCA) scores is associated with post-stroke cognitive decline determined by a formal neuropsychological evaluation. PLoS One. 2017 Mar 27;12(3):e0173291. doi: 10.1371/journal.pone.0173291. eCollection 2017.
- Background: PubMed 28152248van de Bovenkamp HM, Dwarswaard J. The complexity of shaping self-management in daily practice. Health Expect. 2017 Oct;20(5):952-960. doi: 10.1111/hex.12536. Epub 2017 Feb 2.
- Background: PubMed 26549171Koetsenruijter J, van Eikelenboom N, van Lieshout J, Vassilev I, Lionis C, Todorova E, Portillo MC, Foss C, Serrano Gil M, Roukova P, Angelaki A, Mujika A, Knutsen IR, Rogers A, Wensing M. Social support and self-management capabilities in diabetes patients: An international observational study. Patient Educ Couns. 2016 Apr;99(4):638-643. doi: 10.1016/j.pec.2015.10.029. Epub 2015 Nov 2.
- Background: PubMed 20562629Beauchamp A, Peeters A, Tonkin A, Turrell G. Best practice for prevention and treatment of cardiovascular disease through an equity lens: a review. Eur J Cardiovasc Prev Rehabil. 2010 Oct;17(5):599-606. doi: 10.1097/HJR.0b013e328339cc99.
- Background: PubMed 22353433Solomon M, Wagner SL, Goes J. Effects of a Web-based intervention for adults with chronic conditions on patient activation: online randomized controlled trial. J Med Internet Res. 2012 Feb 21;14(1):e32. doi: 10.2196/jmir.1924.
- Results publicationEpidemiology & Disease Control Division, et al., The Burden of Disease in Singapore, 1990-2017: An overview of the Global Burden of Disease Study 2017results. 2019: Seattle, WA: IHME
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivien Xi Wu, PhD principal investigator
National University of Singapore
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based E-Health Program and usual self-management and follow up with doctors/nurse in people with Diabetes Mellitus and Hypertension, run by National University of Singapore at 9 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-care ability of Chronic disease (time frame: baseline, 3 month, 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04560296, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.