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Salutogenic Healthy Aging Program Embracement (SHAPE) for Elderly-only Households (SHAPE)

This study is not yet open for participant recruitment.
Verified May 2017 by Wang Wenru, National University, Singapore
Sponsor:
ClinicalTrials.gov Identifier:
NCT03147625
First Posted: May 10, 2017
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Boon Lay Constituency
Ministry of Education, Singapore
Information provided by (Responsible Party):
Wang Wenru, National University, Singapore
  Purpose

Elderly residing in elderly-only households are more vulnerable as they are socially isolated, suffer from poorer health outcomes, and are less likely to adopt health-promoting behaviors. While multi-dimensional preventive home visits provide older adults with the individualized care to cope with living in their homes, group-based education promotes peer learning and allows for social interaction. Elderly residing in elderly-only households can reap the benefits derived from the coaction of preventive home visits and group-based education, providing them with the personalized care to age healthily in their homes and a platform to develop social connectedness with their peers. This study uses the combination of preventive home visit and group-based education program to promote healthy aging in elderly living in elderly-only households.

Using a randomized controlled trial, the study aims to evaluate the effectiveness of a 12-week health promotion and risk prevention program, named Salutogenic Healthy Aging Program Embracement (SHAPE) for elderly-only households. Participants in the experimental group will receive 2 home visits, 10-weekly group-based activity sessions and a SHAPE health-promotion booklet. A process evaluation using face-to-face interviews will also be conducted for elderly receiving SHAPE to explore their views on the program.

The use of salutogenic model breaks away from the negatively connoted conventional biomedical model and addresses on optimization of positive health. Ultimately, the SHAPE intervention seeks to identify, equip and strengthen resources for elderly-only households, encouraging the adaption of health-promoting and risk-preventing actions to achieve better health outcomes and higher quality of life.


Condition Intervention
Elderly Behavioral: SHAPE Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
In this two-armed randomized controlled trial, participants will be allocated to either the intervention group or the control group through stratified permuted block randomization. Participants in the intervention will undergo SHAPE while participants assigned to the control group will receive usual care, which refers to existing community services provided by the local community centre, senior activity centre and voluntary welfare organisations.
Masking: Single (Outcomes Assessor)
Masking Description:
A research nurse not involved in the delivery of SHAPE intervention will be blinded to the participants' group assignment to conduct data collection.
Primary Purpose: Supportive Care
Official Title: Salutogenic Healthy Aging Program Embracement (SHAPE) for Elderly-only Households

Further study details as provided by Wang Wenru, National University, Singapore:

Primary Outcome Measures:
  • Change in Sense of Coherence [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    Sense of coherence refers to one's ability to comprehend, make sense of and mobilize resources to cope with stressors. The 13-item Orientation to Life Questionnaire (SOC-13) measuring sense of coherence consists of 3 domains: comprehensibility (5-item), manageability (4-item) and meaningfulness (4-item). The higher the score, the better the sense of coherence.


Secondary Outcome Measures:
  • Change in Quality of Life [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    The World Health Organisation Quality of Life- Older Adults questionnaire (WHOQoL-OLD) is a 24-item valid and reliable cross-cultural geriatric-centric instrument consisting of 6 subscales: sensory abilities, autonomy, past, present and future, social participation, death and dying and intimacy. The total score ranges from 24 to 120, with higher scores suggesting higher quality of life.

  • Change in Self-rated Health [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    Participants will be asked to rate their own health on both the self-rated health likert-scale item, as well as the self-rated health visual analogue scale from EQ-5D instrument (range 0 to 100).

  • Change in Health-Promoting behaviors [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    The Health promotion lifestyle profile-II (HPLP-II) is an established instrument measuring multi-components of health promotion lifestyle behaviors.It uses 4-point likert scale (4-routinely to 1-never) to reflect how often the individual engages in the listed health-promoting behavior. The total score ranges from 30 to 120, with higher scores suggesting greater engagement in health promoting behaviors.

  • Change in Self-efficacy [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    The Generalised Self-efficacy Scale (GSE) was developed to assess perceived self-efficacy with the intention to predict coping with daily events and adaptation of stressful life events. It has 10 items and they are rated on a 4-point likert scale. A higher score indicates better ability to cope with stressful situations.

  • Change in Instrumental Activities of Daily Living [ Time Frame: Baseline, 12 months ]
    The Lawton's Instrument Activities of Daily Living (IADLs) instrument is used to assess one's independent living skills. Higher total scores portray higher independence and functional ability of an individual

  • Change in Functional Mobility [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    The Time-Up Go test (TUGT) is a simple, quick and widely used clinical test to assess lower extremity function, mobility and fall risk, even in healthy older adults. Participants will be asked to stand up from a standard chair, walk a distance of three metres, turn, walk back and sit down. While routine walking aids are allowed, they are not permitted to use their arms to stand up and no physical assistance is offered. A stopwatch will be used to record the time to complete the task and the average time of 2 attempts will be taken as a reading. Shorter times reflect better functional mobility.

  • Change in Blood Pressure [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    Participants are to rest and stabilize for 10 minutes before taking their systolic and diastolic using a standard mercury sphygmomanometer on the right upper arm (unless contraindicated)

  • Change in Fasting Blood glucose [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    Participants will be asked to fast for at least 6 hours prior to test for fasting blood glucose. A standardized glucometer will be used to determine the reading of fasting blood glucose.

  • Change in Body Mass Index [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    A standardised weighing machine and measuring tape will be used to measure the height and weight of the participant.

  • Change in Cognitive function [ Time Frame: Baseline, 12 months ]
    The Mini Mental State Examination (MMSE) is used to assess and detect for any cognitive impairment. The summed scores of MMSE range from 0-30. The higher the score, the better the cognitive function.

  • Change in Depressive Symptoms [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    The 15-item Geriatric Depression scale (GDS) was developed to screen for depressive symptoms in older adults and is a well-validated depression screening tool used in Singapore. Its total score range from 0 to 15. The higher the score, the higher one presents with depressive symptoms.

  • Change in Anxiety [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    The 20-item Geriatric Anxiety Inventory (GAI) measures common typical anxiety symptoms in older adults. Its total score ranges from 0 to 20; higher summed scores refers to higher anxiety levels.

  • Change in Perceived Stress [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    The 10-item Perceived Stress Scale (PSS) will be used to assess subjective stress levels in individuals. Its total range from 0 to 40, and higher scores denotes higher perceived stress.

  • Change in Perceived Social Support [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    The Duke Social Support Index (DSSI) will be used to assess subjective social support among elderly. The abbreviated version (DSSI-10) consists of 10 items, each on a 3-point likert scale, and measures the following two constructs: social interaction and social satisfaction. Possible score ranges from 10 to 30 and higher scores reflect higher levels of perceived support support.

  • Change in Hospital admissions [ Time Frame: Baseline, 12 months ]
    Frequency of hospital admissions in the past 12 months


Estimated Enrollment: 154
Anticipated Study Start Date: August 1, 2017
Estimated Study Completion Date: July 31, 2020
Estimated Primary Completion Date: July 31, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SHAPE Intervention
Participants in this group will receive a 12-week SHAPE intervention, comprising of 2 home visits, 10 weekly group-based activity sessions and a SHAPE health-promotion booklet.
Behavioral: SHAPE Intervention
SHAPE seeks to identify, equip and strengthen resources in elderly residing in elderly-only households. The content will be further developed according to the findings of an existing descriptive qualitative study, literature review and a multi-disciplinary expert panel review. The home visit will involve assessment, observation and evaluation of elderly' health status, lifestyle and home environment, followed by guidance on health-promoting behaviour and emphasis on strengthening inner health resources. This provides an individualized approach to enhance personal health skills. Group-based activity sessions are directed to facilitate group interaction among peers as well as equipping and enhancing external resources.
No Intervention: Control group
Participants in the control group will continue to participate in activities offered in the senior activity centre, community centres and voluntary welfare organisations.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • community-dwelling elderly aged 65 years and above,
  • either living by himself/herself or living his/her older spouse or living with an unrelated elderly
  • able to comprehend and converse either in English or Chinese language
  • able to be followed up on home visits.

Exclusion Criteria:

Elderly who

  • have significant cognitive impairment (Mini Mental State ≤ 23)
  • have severe hearing and/or visual impairment
  • have terminal illness with life expectancy <12 months
  • have uncontrolled psychiatric disorders
  • are on home visit follow-ups with other organizations
  • are involved in existing clinical trials.
  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): NCT03147625


Contacts
Contact: Wenru Wang +65 66011761 nurww@nus.edu.sg

Sponsors and Collaborators
National University, Singapore
Boon Lay Constituency
Ministry of Education, Singapore
Investigators
Principal Investigator: Wenru Wang National University, Singapore
  More Information

Responsible Party: Wang Wenru, Assistant Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT03147625     History of Changes
Other Study ID Numbers: MOE-SSTRG
First Submitted: May 5, 2017
First Posted: May 10, 2017
Last Update Posted: May 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wang Wenru, National University, Singapore:
Aged
Independent living
Health Promotion
Residence Characteristics
Elderly-only household