Ignite Creation Date:
2024-05-06 @ 10:02 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03147625
Status:
UNKNOWN
Last Update Posted:
2017-05-10
First Post:
2017-05-05
Brief Title:
Salutogenic Healthy Aging Program Embracement SHAPE for Elderly-only Households
Sponsor:
National University of Singapore
Organization:
National University of Singapore
Study Overview
Official Title:
Salutogenic Healthy Aging Program Embracement SHAPE for Elderly-only Households
Status:
UNKNOWN
Status Verified Date:
2017-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHAPE
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
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 d046-057 Sample size calculation is therefore calculated based on a medium effect size of 05 A minimum sample size of 64 participants in each group is needed to detect a difference between groups at an alpha of 005 and power of 080 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
Intervention Group A 12-week SHAPE intervention comprising of 2 home visits 10 weekly group-based activity sessions and a SHAPE health-promotion booklet is proposed
SHAPE seeks to identify equip and strengthen resources for elderly residing in elderly-only households The content of program will be further developed and mould by the results from an existing qualitative study literature review and by a group of multi-disciplinary expert panel consisting of gerontology-trained nurses physiotherapist occupational therapists and social workers and well-established researchers Homes visits and group-based activity sessions will be conducted by the researchers who are a trained RN and a trained RA A with social work background 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 will provide 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 to the older adults Homework will be given at the end of each session to allow them to reflect on the contents of each session Special considerations will be taken during the design of SHAPE health-promotion booklet to cater to older peoples needs such as larger prints shorter sentences and pictorial examples Two voluntary older adults will also be involved in shaping the content of the booklet
Control GroupUsual Care
Participants in the control group will continue to participate in activities offered in senior activity centres community centres and voluntary welfare organisations
Outcome Measures Sense of coherence quality of life self-rated health health-promoting behaviors self-efficacy functional mobility instrumental activities of daily living body mass index blood pressure fasting blood glucose cognitive function depressive symptoms anxiety perceived stress social support hospital admissions
Semi-structured Interviews Process Evaluation To explore the responsiveness strengths and weaknesses of SHAPE a qualitative face-to-face interview will be conducted after the start of intervention at 6 months Purposive sampling will be used and participants from the experimental group will be interviewed A semi-structured interview guide will be used to explore the perspectives of participants towards the responsiveness and usefulness of SHAPE as well as to understand the strengths and weaknesses of the program and identify areas for future improvement All interviews will be conducted by the researcher till data saturation
Data Collection Upon the approval of ethics the researcher will collaborate with the site-PI from the community and volunteers from residents committee to recruit study participants Eligibility of participants will be assessed face-to-face by researcher nurse before obtaining informed consent Data on socio-demographics past medical history and health conditions will also be collected Data will be collected at 4 different intervals baseline pre-test 3 months post-test 1 6 months post-test 2 and 12 months post-test 3 from the baseline The RA B will arrange appointment with participants to collect the data through face-to-face interview as some older adults might be illiterate and are unable to self-administer the questionnaire
Data Analysis Data will be analysed using SPSS version 24 Baseline categorical demographic characteristics between the experimental and control groups will be examined using Chi-squared or Fishers Exact test Independent t-test will be used for quantitative variables if normality and homogeneity assumptions are satisfied otherwise Mann-Whitney U-test will be used Repeated measures analysis of variance ANOVA will be performed to analyse the interaction effect time x group between two groups on numerical outcomes over time setting level of significance at p005 for two-tailed test In addition General Linear Mixed Model GLM will be used to compare the study outcomes between two groups at each time point To correct for type 1 error on multiple comparisons for each time point statistical significance will be set at p 001
Qualitative thematic analysis will be used to analyse the data collected from the interviews All interviews are audio-taped Interviews will be conducted and transcribed in either in Chinese or English language respectively Co-researcher will check for any discrepancy between the English and Chinese transcripts to ensure the congruency of meaning in data
Potential impact The SHAPE intervention aims to equip older adults living alone with both internal and external resources and encourage the adaption of health-promoting and risk-preventing behaviours to promote healthy aging Targeting on the group of vulnerable and poorer older population the program seeks to optimize health by enhancing ones ability to cope with health and age-related stressors and promote independent living preventing functional dependence
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 d046-057 Sample size calculation is therefore calculated based on a medium effect size of 05 A minimum sample size of 64 participants in each group is needed to detect a difference between groups at an alpha of 005 and power of 080 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
Intervention Group A 12-week SHAPE intervention comprising of 2 home visits 10 weekly group-based activity sessions and a SHAPE health-promotion booklet is proposed
SHAPE seeks to identify equip and strengthen resources for elderly residing in elderly-only households The content of program will be further developed and mould by the results from an existing qualitative study literature review and by a group of multi-disciplinary expert panel consisting of gerontology-trained nurses physiotherapist occupational therapists and social workers and well-established researchers Homes visits and group-based activity sessions will be conducted by the researchers who are a trained RN and a trained RA A with social work background 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 will provide 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 to the older adults Homework will be given at the end of each session to allow them to reflect on the contents of each session Special considerations will be taken during the design of SHAPE health-promotion booklet to cater to older peoples needs such as larger prints shorter sentences and pictorial examples Two voluntary older adults will also be involved in shaping the content of the booklet
Control GroupUsual Care
Participants in the control group will continue to participate in activities offered in senior activity centres community centres and voluntary welfare organisations
Outcome Measures Sense of coherence quality of life self-rated health health-promoting behaviors self-efficacy functional mobility instrumental activities of daily living body mass index blood pressure fasting blood glucose cognitive function depressive symptoms anxiety perceived stress social support hospital admissions
Semi-structured Interviews Process Evaluation To explore the responsiveness strengths and weaknesses of SHAPE a qualitative face-to-face interview will be conducted after the start of intervention at 6 months Purposive sampling will be used and participants from the experimental group will be interviewed A semi-structured interview guide will be used to explore the perspectives of participants towards the responsiveness and usefulness of SHAPE as well as to understand the strengths and weaknesses of the program and identify areas for future improvement All interviews will be conducted by the researcher till data saturation
Data Collection Upon the approval of ethics the researcher will collaborate with the site-PI from the community and volunteers from residents committee to recruit study participants Eligibility of participants will be assessed face-to-face by researcher nurse before obtaining informed consent Data on socio-demographics past medical history and health conditions will also be collected Data will be collected at 4 different intervals baseline pre-test 3 months post-test 1 6 months post-test 2 and 12 months post-test 3 from the baseline The RA B will arrange appointment with participants to collect the data through face-to-face interview as some older adults might be illiterate and are unable to self-administer the questionnaire
Data Analysis Data will be analysed using SPSS version 24 Baseline categorical demographic characteristics between the experimental and control groups will be examined using Chi-squared or Fishers Exact test Independent t-test will be used for quantitative variables if normality and homogeneity assumptions are satisfied otherwise Mann-Whitney U-test will be used Repeated measures analysis of variance ANOVA will be performed to analyse the interaction effect time x group between two groups on numerical outcomes over time setting level of significance at p005 for two-tailed test In addition General Linear Mixed Model GLM will be used to compare the study outcomes between two groups at each time point To correct for type 1 error on multiple comparisons for each time point statistical significance will be set at p 001
Qualitative thematic analysis will be used to analyse the data collected from the interviews All interviews are audio-taped Interviews will be conducted and transcribed in either in Chinese or English language respectively Co-researcher will check for any discrepancy between the English and Chinese transcripts to ensure the congruency of meaning in data
Potential impact The SHAPE intervention aims to equip older adults living alone with both internal and external resources and encourage the adaption of health-promoting and risk-preventing behaviours to promote healthy aging Targeting on the group of vulnerable and poorer older population the program seeks to optimize health by enhancing ones ability to cope with health and age-related stressors and promote independent living preventing functional dependence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None