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Community-based E-Health Program for Older Adults Living With Chronic Diseases (CeHP)

Primary Purpose

Diabetes Mellitus, Hypertension, Hyperlipidemias

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Community-based E-Health Program
usual self-management and follow up with doctors/nurse
Sponsored by
National University of Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus focused on measuring community-dwelling older adults, chronic diseases, self-management, e-health, cognitive impairment

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • THK SAC @ Bedok RadianceRecruiting
  • THK SAC @ Kaki Bukit
  • Presbyterian Community Services - Evergreen Circle Seniors Activity Centre
  • Lb Sac (Sa) @ Tampines 494ERecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Community-based E-Health Program

usual self-management and follow up with doctors/nurse

Arm Description

The intervention group will consist of 80 participants who will engage in Community-based E-Health Program.

The participants will receive the usual self-management and follow up with doctors/nurse as planned.

Outcomes

Primary Outcome Measures

Change in Self-care ability of Chronic disease
Self-care of Chronic Illness Inventory

Secondary Outcome Measures

Change in Patient Empowerment
Patient Empowerment scale
Change in Health Literacy
Health Literacy Scale, minimum value is 12, maximum value is 48, higher scores mean a better outcome.
Change in Social support
Social support Questionnaire
Change in Healthy Aging practice
Healthy Aging Instrument
Cognition
Montreal Cognitive Assessment
Cognition
Symbol Digit modality test
HbA1c
glycemic control

Full Information

First Posted
September 3, 2020
Last Updated
December 16, 2021
Sponsor
National University of Singapore
Collaborators
Changi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04560296
Brief Title
Community-based E-Health Program for Older Adults Living With Chronic Diseases
Acronym
CeHP
Official Title
Community-based E-Health Program for Older Adults Living With Chronic Diseases - A Cluster Randomized Controlled Study With Process Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore
Collaborators
Changi General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Hypertension, Hyperlipidemias
Keywords
community-dwelling older adults, chronic diseases, self-management, e-health, cognitive impairment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster Randomized Controlled Study
Masking
Participant
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Community-based E-Health Program
Arm Type
Experimental
Arm Description
The intervention group will consist of 80 participants who will engage in Community-based E-Health Program.
Arm Title
usual self-management and follow up with doctors/nurse
Arm Type
Active Comparator
Arm Description
The participants will receive the usual self-management and follow up with doctors/nurse as planned.
Intervention Type
Behavioral
Intervention Name(s)
Community-based E-Health Program
Intervention Description
Community-based E-Health Program will be developed to engage and empower older adults to manage the chronic conditions effectively.
Intervention Type
Behavioral
Intervention Name(s)
usual self-management and follow up with doctors/nurse
Intervention Description
usual self-management and follow up with doctors/nurse as planned in the community nurse post.
Primary Outcome Measure Information:
Title
Change in Self-care ability of Chronic disease
Description
Self-care of Chronic Illness Inventory
Time Frame
baseline, 3 month
Secondary Outcome Measure Information:
Title
Change in Patient Empowerment
Description
Patient Empowerment scale
Time Frame
baseline, 3 month
Title
Change in Health Literacy
Description
Health Literacy Scale, minimum value is 12, maximum value is 48, higher scores mean a better outcome.
Time Frame
baseline, 3 month
Title
Change in Social support
Description
Social support Questionnaire
Time Frame
baseline, 3 month
Title
Change in Healthy Aging practice
Description
Healthy Aging Instrument
Time Frame
baseline, 3 month
Title
Cognition
Description
Montreal Cognitive Assessment
Time Frame
baseline, 3 month
Title
Cognition
Description
Symbol Digit modality test
Time Frame
baseline, 3 month
Title
HbA1c
Description
glycemic control
Time Frame
baseline, 3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: aged 55 or above; able to understand and communicate in either English or Mandarin; able to give consent to participate; lives within the community setting; diagnosed with chronic conditions (Hypertension, Hyperlipidemia, and Diabetes Mellites); 6) able to commit to five-hour learning. Exclusion Criteria: severe cognitive impairment; severe psychiatric disorders; severe vision impairment; severe hearing impairment.
Facility Information:
Facility Name
THK SAC @ Bedok Radiance
City
Singapore
ZIP/Postal Code
460012
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelyn Lee
Phone
62422483
Email
leemeowling@thkmc.org.sg
Facility Name
THK SAC @ Kaki Bukit
City
Singapore
ZIP/Postal Code
462509
Country
Singapore
Individual Site Status
Active, not recruiting
Facility Name
Presbyterian Community Services - Evergreen Circle Seniors Activity Centre
City
Singapore
ZIP/Postal Code
521827
Country
Singapore
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jimmy Tan
Phone
67866826
Email
jimmytan@pcs.org.sg
Facility Name
Lb Sac (Sa) @ Tampines 494E
City
Singapore
ZIP/Postal Code
525494
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy Mok
Phone
66814925
Email
jeremy.mok@lb.org.sg

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29793001
Citation
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Results Reference
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PubMed Identifier
27567871
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.
Results Reference
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PubMed Identifier
28346532
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.
Results Reference
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PubMed Identifier
28152248
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.
Results Reference
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PubMed Identifier
26549171
Citation
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.
Results Reference
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PubMed Identifier
20562629
Citation
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.
Results Reference
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PubMed Identifier
22353433
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.
Results Reference
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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
Results Reference
result

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Community-based E-Health Program for Older Adults Living With Chronic Diseases

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