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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04560296
Other study ID # NUHSRO/2019/081/Startup/06
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2020
Est. completion date December 30, 2023

Study information

Verified date December 2021
Source National University, Singapore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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 randomized controlled trial (RCT) 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.


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 randomized controlled trial (RCT) 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date December 30, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years and older
Eligibility Inclusion Criteria: 1. aged 55 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 five-hour learning. Exclusion Criteria: 1. severe cognitive impairment; 2. severe psychiatric disorders; 3. severe vision impairment; 4. severe hearing impairment.

Study Design


Intervention

Behavioral:
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.
usual self-management and follow up with doctors/nurse
usual self-management and follow up with doctors/nurse as planned in the community nurse post.

Locations

Country Name City State
Singapore Lb Sac (Sa) @ Tampines 494E Singapore
Singapore Presbyterian Community Services - Evergreen Circle Seniors Activity Centre Singapore
Singapore THK SAC @ Bedok Radiance Singapore
Singapore THK SAC @ Kaki Bukit Singapore

Sponsors (2)

Lead Sponsor Collaborator
National University, Singapore Changi General Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (8)

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. Review. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Self-care ability of Chronic disease Self-care of Chronic Illness Inventory baseline, 3 month
Secondary Change in Patient Empowerment Patient Empowerment scale baseline, 3 month
Secondary Change in Health Literacy Health Literacy Scale, minimum value is 12, maximum value is 48, higher scores mean a better outcome. baseline, 3 month
Secondary Change in Social support Social support Questionnaire baseline, 3 month
Secondary Change in Healthy Aging practice Healthy Aging Instrument baseline, 3 month
Secondary Cognition Montreal Cognitive Assessment baseline, 3 month
Secondary Cognition Symbol Digit modality test baseline, 3 month
Secondary HbA1c glycemic control baseline, 3 month
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