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

NCT03147625 | Unknown DMC

• 1 other identifier: MOE-SSTRG
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Elderly

Keywords

Aged; Independent living; Health Promotion; Residence Characteristics; Elderly-only household

Outcome Measures

Primary Outcomes (1)

• Change in Sense of Coherence

  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.

  Baseline, 3 months, 6 months, 12 months

Secondary Outcomes (15)

• Change in Quality of Life

  Baseline, 3 months, 6 months, 12 months

• Change in Self-rated Health

  Baseline, 3 months, 6 months, 12 months

• Change in Health-Promoting behaviors

  Baseline, 3 months, 6 months, 12 months

• Change in Self-efficacy

  Baseline, 3 months, 6 months, 12 months

• Change in Instrumental Activities of Daily Living

  Baseline, 12 months

Study Arms (2)

SHAPE Intervention

EXPERIMENTAL

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

Control group

NO INTERVENTION

Participants in the control group will continue to participate in activities offered in the senior activity centre, community centres and voluntary welfare organisations.

Interventions

SHAPE Intervention BEHAVIORAL

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.

SHAPE Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Singapore: lead
• Boon Lay Constituency: collaborator
• Ministry of Education, Singapore: collaborator

Related Publications (2)

• Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.

  PMID: 39360568 DERIVED

• Seah B, Espnes GA, Hong WT, Wang W. Salutogenic Healthy Ageing Programme Embracement (SHAPE)- an upstream health resource intervention for older adults living alone and with their spouses only: complex intervention development and pilot randomized controlled trial. BMC Geriatr. 2022 Dec 3;22(1):932. doi: 10.1186/s12877-022-03605-3.

  PMID: 36460959 DERIVED

Study Officials

• Wenru Wang

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenru Wang

CONTACT

+65 66011761; nurww@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A research nurse not involved in the delivery of SHAPE intervention will be blinded to the participants' group assignment to conduct data collection.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 10, 2017
• Study Start: August 1, 2017
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share