- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04560296
Community-based E-Health Program for Older Adults Living with Chronic Diseases (CeHP)
Community-based E-Health Program for Older Adults Living with Chronic Diseases - a Cluster Controlled Study with Process Evaluation
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Singapore, Singapore, 460012
- THK SAC @ Bedok Radiance
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Singapore, Singapore, 462509
- THK SAC @ Kaki Bukit
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Singapore, Singapore, 520209
- Pap Community Foundation 3-in-1 Family Centre (Aged Care)
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Singapore, Singapore, 520227
- Brahm Centre @ Simei 227
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Singapore, Singapore, 520434
- Lb Sac @ 434 Tampines
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Singapore, Singapore, 520473
- Brahm Centre @ Tampines
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Singapore, Singapore, 521827
- Presbyterian Community Services - Evergreen Circle Seniors Activity Centre
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Singapore, Singapore, 523499
- Lb Sac @ 499C Tampines
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Singapore, Singapore, 525494
- Lb Sac (Sa) @ Tampines 494E
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- severe cognitive impairment;
- severe psychiatric disorders;
- severe vision impairment;
- severe hearing impairment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Community-based E-Health Program
The intervention group will consist of 80 participants who will engage in Community-based E-Health Program.
|
Community-based E-Health Program will be developed to engage and empower older adults to manage the chronic conditions effectively.
|
|
Active Comparator: usual self-management and follow up with doctors/nurse
The participants will receive the usual self-management and follow up with doctors/nurse as planned.
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usual self-management and follow up with doctors/nurse as planned in the community nurse post.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Self-care ability of Chronic disease
Time Frame: baseline, 3 month, 6 month
|
Self-care of Chronic Illness Inventory
|
baseline, 3 month, 6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HbA1c
Time Frame: baseline, 3 month
|
glycemic control
|
baseline, 3 month
|
|
Change in Patient Empowerment
Time Frame: baseline, 3 month, 6 month
|
Patient Empowerment scale
|
baseline, 3 month, 6 month
|
|
Change in Health Literacy
Time Frame: baseline, 3 month, 6 month
|
Health Literacy Scale, minimum value is 12, maximum value is 48, higher scores mean a better outcome.
|
baseline, 3 month, 6 month
|
|
Change in Social support
Time Frame: baseline, 3 month, 6 month
|
Social support Questionnaire
|
baseline, 3 month, 6 month
|
|
Change in Healthy Aging practice
Time Frame: baseline, 3 month, 6 month
|
Healthy Aging Instrument
|
baseline, 3 month, 6 month
|
|
Montreal Cognitive Assessment
Time Frame: baseline, 3 month, 6 month
|
Singapore version 2010
|
baseline, 3 month, 6 month
|
|
Symbol Digit modality test
Time Frame: baseline, 3 month, 6 month
|
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
|
baseline, 3 month, 6 month
|
|
Lipid panel
Time Frame: baseline, 3 month
|
HDL, LDL, triglycerides
|
baseline, 3 month
|
|
Immunological profile
Time Frame: baseline, 3 month
|
Cytokines (IL-1, IL6, IL15), TNFa, C1q, antinuclear antibody, antiDNA antibody
|
baseline, 3 month
|
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Hormones
Time Frame: baseline, 3 month
|
Cortisol, DHEA, insulin
|
baseline, 3 month
|
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Fasting glucose
Time Frame: baseline, 3 month
|
Plasma glucose concentration after fasting for 8 hours
|
baseline, 3 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Vivien Xi Wu, PhD, National University of Singapore
Publications and helpful links
General Publications
- Solomon 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.
- 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.
- Vijayan 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.
- Tan 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.
- van 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.
- Koetsenruijter 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.
- Beauchamp 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.
- Epidemiology & 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUHSRO/2019/081/Startup/06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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