Salutogenic Healthy Aging Program Embracement (SHAPE) for Elderly-only Households
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 154
- Primary Endpoint
- Change in Sense of Coherence
Study Overview
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.
Detailed Description
Aim and Hypothesis This study aims to develop and evaluate the effectiveness of a multi-dimensional, community-based health promotion and prevention program, SHAPE, on sense of coherence, self-efficacy, quality of life, health-promoting behaviours, and health-related outcomes among elderly residing in elderly-only households in Singapore.
It is hypothesized that compared with participants in the control group, participants in the experimental group will have improved sense of coherence, better quality of life, increase uptake of health-promoting behaviours, higher self-efficacy and other health outcomes.
Study Design A single-blinded two-arm, randomized controlled trial (RCT), pretest and repeated post-test design will be used. The study will be conducted in a small residential estate located in the west of Singapore. Stratified permuted block randomization will be used to allocate participants into experimental and control group. The 12-week SHAPE will be provided to elderly living in the blocks allocated to the experimental group, and both groups will receive usual activities offered in senior activity centre, community centre and voluntary welfare organisations. One research nurse (RN) together with a research assistant A (RA A) who has social work background will conduct the intervention, and another research assistant B (RA B) will conduct the data collection. The RA B will be blinded to participants' group assignment to prevent subjective bias stemming from the knowledge of grouping. Four measurements will be conducted at baseline prior to the intervention, at 3 months immediately after the intervention, 6 months, and 12 months from the baseline.
Sample Size Power analysis calculation on sample size is based on previous studies on community-based programs conducted in community-dwelling older adults which reported sense of coherence having a medium effect size (d=0.46-0.57). Sample size calculation is therefore calculated based on a medium effect size of 0.5. A minimum sample size of 64 participants in each group is needed to detect a difference between groups at an alpha of 0.05 and power of 0.80. We estimate 20% attrition rate, a total of 154 participants would be needed, with 77 in each group
Randomization To account for differences in living arrangement and ensure that elderly living in the same household are assigned to the same intervention or control group, stratified permuted block randomization will be used in this study. Participants will be grouped according to either of the three strata: (1) single elderly in a household, (2) two elderly from same household participating in the trial (a pair) and (3) only one out of two elderly from same household participating in the trial. Blocks of 10, with the assignment of 5 to experimental group and 5 to control group, will be used for each strata. Using a computerized randomization software, a statistician will generate the randomization list and prepare 3 different sets of sealed envelopes. According to their strata, the participant or the pair of participants will choose from the respective set of envelopes themselves to determine the group assignment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- 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.
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: SHAPE Intervention (Behavioral)
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.
Outcomes
Primary Outcomes
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 Outcomes
- Change in Body Mass Index(Baseline, 3 months, 6 months, 12 months)
- Change in Blood Pressure(Baseline, 3 months, 6 months, 12 months)
- Change in Cognitive function(Baseline, 12 months)
- Change in Depressive Symptoms(Baseline, 3 months, 6 months, 12 months)
- Change in Anxiety(Baseline, 3 months, 6 months, 12 months)
- Change in Perceived Stress(Baseline, 3 months, 6 months, 12 months)
- Change in Perceived Social Support(Baseline, 3 months, 6 months, 12 months)
- Change in Hospital admissions(Baseline, 12 months)
- Change in Functional Mobility(Baseline, 3 months, 6 months, 12 months)
- Change in Fasting Blood glucose(Baseline, 3 months, 6 months, 12 months)
- Change in Quality of Life(Baseline, 3 months, 6 months, 12 months)
- Change in Instrumental Activities of Daily Living(Baseline, 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)
Investigators
Wang Wenru
Assistant Professor
National University of Singapore