Self Care for Older Persons in Singapore: An Intervention Study (SCOPE)

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ClinicalTrials.gov Identifier: NCT01672177

Recruitment Status : Completed

First Posted : August 24, 2012

Last Update Posted : April 16, 2015

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Dr. David Matchar, National University of Singapore

Study Description

Brief Summary:

The main aim of the project is to evaluate a self-care intervention program aimed at enhancing the ability of mildly disabled and healthy older persons in Singapore to manage their health.

A secondary aim of the study is to evaluate the effectiveness of training community health workers located within Senior Activity Centres in Singapore to support the self-care capacity development amongst older persons in the locale.

Condition or disease	Intervention/treatment	Phase
Health Services, Geriatric	Behavioral: Chronic disease self-management training	Not Applicable

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Detailed Description:

Singapore is facing a rapidly ageing population due to its changing demographics. One of the biggest challenges associated with older adults is providing them with adequate and sustainable health care. There are four main barriers that make it challenging to do so in this segment of the population: (1) Lack of knowledge of simple coping mechanisms and self care; (2) inadequate access to care and healthcare; (3) social, economic, and political exclusion; and (4) declining family support and strains on state services.

This proposal, is to conduct a randomized controlled trial that tests the impact of a state-of-the-art self care training program focused on teaching older adults how to manage their health and if present, their diabetes, hypertension or chronic obstructive pulmonary disease. The training focuses on health promotion, disease prevention, health seeking behavior, chronic disease management and empowerment. The study period is 18 months with measurements taken at baseline, 8 months and 18 months. Major events (stroke, myocardial infarction, end-stage renal disease, hospitalization, deaths) during the study will also be recorded. A questionnaire assessing functional status (IADL), quality of life (EQ5D), knowledge and attitude about health care, health seeking behavior, and health status (CIRS-G) will be used. Anthropometric measures will also be taken to better understand certain aspects related to the health and physical status of the participants as well as biomarkers such as the levels of glycosylated hemoglobin (HbA1c), cholesterol (total HDL), triglycerides, blood pressure and peak expiratory flow.

The main goal of the study is to improve each individual score and to measure improvement in overall quality of life and mental well-being. The total sample size for this pilot study is 400 older persons (above 55 years of age) randomly sampled from Tiong Bahru/Bukit Merah and Ang Mo Kio. The health care training will be based in Senior Activity Centres (SACs) located in HDB blocks. The investigators will select 12 SACs and randomly assign 6 SACs to the intervention group and 6 SACs to the control group. All twelve groups will receive a baseline assessment of physical and mental health status and a follow-up at 8 and 18 months. Two community health trainers (CHT) will be assigned to each of the intervention groups. These CHTs will have been trained by personnel at the Tsao Foundation to conduct the training protocol and collect data from participants. The intervention group will then receive the health care training once a week for 2 hours over a period of seven-eight months (56 hours total). The content of training materials focuses on health promotion, disease prevention, health seeking behavior, chronic disease management, and anti-stigmatization. In addition, each participant, regardless of randomization, will be given an event diary at baseline. The diary will be used to record any health related events that occur during the course of the study. Such events would include visits to GPs or traditional medicine practitioners, purchasing medications, hospitalization, etc.

The investigators hypothesize that the study will demonstrate the following: 1) Improve chronic disease outcomes for individuals presenting with these diseases: hypertension (20% decrease in systolic blood pressure), diabetes (1% decrease in HBA1C levels), and COPD (10% increase in peak expiratory flow) over the 18-month study period. 2) Improve quality of life of participants and their caregivers. 3) Improve knowledge, behaviours and attitudes towards health care utilization. 4) Develop a community health worker capacity in low-income settings. 5) Reduce the number of hospitalizations, outpatient and emergency visits in the intervention group.

This pilot study will also allow the investigators to test their methods for recruitment, training, and evaluation of the self-care training program. If successful, this study will provide evidence that older adults in the intervention group can more effectively manage their own health care and avert or delay the onset of disability compared to older adults in the control group. One of the long term goals is to replicate this study in Cambodia, India, Indonesia, and Vietnam. The investigators have identified academic and practice partners in each of these countries who have expressed an interest in the project and donors are awaiting the results from this pilot study before funding the regional components.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	400 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Health Services Research
Official Title:	Self Care for Older Persons in Singapore: An Intervention Study
Study Start Date :	August 2011
Actual Primary Completion Date :	October 2014
Actual Study Completion Date :	October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coping with Chronic Illness

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control Individuals in the control group will not receive any training.
Experimental: Intervention Individuals in the intervention group will receive two hour long weekly training sessions for seven to eight months. The content of the training focuses on health promotion, health seeking behaviours and chronic disease management.	Behavioral: Chronic disease self-management training Those in the intervention group will receive two hour long weekly training sessions for seven-eight months (a total of 56 hours of training).

Outcome Measures

Primary Outcome Measures :

Clinical Measures [ Time Frame: 18 months ]
The primary outcome measure is a composite of the change in the following measures: 1)Systolic BP; 2)HbA1C; and 3)normalized peak flow. The null hypothesis is that there is no difference between intervention and control in any of the measures.

Secondary Outcome Measures :

Improved Quality of Life [ Time Frame: 18 months ]
Improve quality of life of participants and their caregivers using a validated measure (EQ-5D).
Community Health Trainer [ Time Frame: 18 months ]
Develop a community health trainer capacity in low-income settings as assessed by numbers of individuals who successfully complete the health trainer education.
Healthcare Utilization [ Time Frame: 18 months ]
Reduce the number of hospitalizations, outpatient and emergency visits in the intervention group vs control.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	55 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age 55 and above
Age 21 or above for CHTs
No cognitive impairment as justified by AMT
No Activities of Daily Living (ADL)Limitations preventing them from coming to questionnaire interviews, health screenings, and/or weekly health trainings.
Not severely ill ; not on dialysis, chemotherapy or psychiatric medication

Exclusion Criteria:

Below 55 years of age
Cognitively impaired
Severely depressed
With ADLs preventing them from coming to questionnaire interviews, health screenings, and/or weekly health trainings.
Severely ill ; on dialysis, chemotherapy or psychiatric medication
Those who refused to have their biomarkers taken (applies to both intervention and non-intervention group)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672177

Locations

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Singapore
Redhill SilverACE
Singapore, Singapore, 150071
Moral Seniors Activity Centre (Redhill)
Singapore, Singapore, 150089
Moral Neighbourhood Link Bukit Merah View/Tanjong Pagar FSC
Singapore, Singapore, 150118
Kreta Ayer Seniors Activity Centre (Chin Swee)
Singapore, Singapore, 160051
Sarah Seniors Activity Centre
Singapore, Singapore, 160105
Kreta Ayer Senior Activity Centre (Jalan Kukoh)
Singapore, Singapore, 162008
AWWA Seniors Activity Centre
Singapore, Singapore, 560123
Ang Mo Kio Family Services Centre
Singapore, Singapore, 560230
Community Care Network Senior Activity Centre @Teck Ghee 420
Singapore, Singapore, 560420
Care Corner Toa Payoh
Singapore, Singapore
Lion Befrienders/TOUCH
Singapore, Singapore
Moral Neighbourhood Link Telok Blangah
Singapore, Singapore

Sponsors and Collaborators

National University of Singapore

Investigators

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Principal Investigator:	David B Matchar, MD	Duke-NUS Graduate Medical School

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ng TKS, Matchar DB, Sultana R, Chan A. Effects of Self-Care for Older PErsons (SCOPE) on Functional and Physiological Measures: A Cluster Randomized Controlled Trial. J Clin Med. 2020 Mar 24;9(3):885. doi: 10.3390/jcm9030885.

Chan A, Matchar DB, Tsao MA, Harding S, Chiu CT, Tay B, Raman P, Pietryla Z, Klein MK, Haldane VE. Self-Care for Older People (SCOPE): a cluster randomized controlled trial of self-care training and health outcomes in low-income elderly in Singapore. Contemp Clin Trials. 2015 Mar;41:313-24. doi: 10.1016/j.cct.2015.01.001. Epub 2015 Jan 10.

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Responsible Party:	Dr. David Matchar, Professor and Director, Program in Health Services and Systems Research, National University of Singapore
ClinicalTrials.gov Identifier:	NCT01672177
Other Study ID Numbers:	MOE2010-T2-2-107
First Posted:	August 24, 2012 Key Record Dates
Last Update Posted:	April 16, 2015
Last Verified:	April 2015

Keywords provided by Dr. David Matchar, National University of Singapore:


Geriatrics Aged Aging Chronic disease Self management

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