Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270862
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-01-01
Brief Title:
A Digital Active Aging Training Program for Older Adults
Sponsor:
Toronto Metropolitan University
Organization:
Toronto Metropolitan University
Study Overview
Official Title:
A Digital Active Aging Training Program for Older Adults
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
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:
AAT
Brief Summary:
The proposed project aims to develop and validate a multi-dimensional digital active aging program integrated with resilience to promote the biopsychosocial functions of older adults aged 60 including Chinese older immigrants in Canada Study 1 and English-speaking White Canadian older adults Study 2
The proposed study takes a typical pretest-training-posttest design Pretest and posttest a battery of outcome measures on physical psychological and social functions will be administered to all participants Data will also be used to identify sociodemographic risk predictors for outcome variables ie biopsychosocial functions and resilience Training the participants will be randomly assigned to three arms to receive 4 weeks of 16 trainingpracticecontrol treatment sessions delivered via Zoom
In the active aging with resilience AR condition participants will complete physical cognitive and social engagement training modules starting with a 30-min resilience-building module The traditional active aging AA training involves the same multi-domain active aging training without the initial resilience-building module The workshop training WT control condition involves workshops following the same 4-week schedule on aging-related topics
The proposed study takes a typical pretest-training-posttest design Pretest and posttest a battery of outcome measures on physical psychological and social functions will be administered to all participants Data will also be used to identify sociodemographic risk predictors for outcome variables ie biopsychosocial functions and resilience Training the participants will be randomly assigned to three arms to receive 4 weeks of 16 trainingpracticecontrol treatment sessions delivered via Zoom
In the active aging with resilience AR condition participants will complete physical cognitive and social engagement training modules starting with a 30-min resilience-building module The traditional active aging AA training involves the same multi-domain active aging training without the initial resilience-building module The workshop training WT control condition involves workshops following the same 4-week schedule on aging-related topics
Detailed Description:
Objectives
1 to develop a multi-domain digital active aging training program through Zoom to promote active aging and
2 to evaluate whether adding a resilience-building module would enhance the active aging training efficacy to mitigate the lingering detrimental impacts of the pandemic
Sample
For Study 1 the investigators will recruit 120 Mandarin-speaking healthy older Chinese immigrants aged 60 Chinese migrants through WeChata popular instant messaging app among Chineseemaillab website social media channels eg Facebook Twitter from the community partners see a list attached For Study 2 we will recruit 120 English-speaking healthy White Canadian older adults aged 60 through TMSPSS the senior participant pool at Toronto Metropolitan University or advertisements
Overall Design and Procedure
Informed consent will be collected The proposed study will take a traditional pretest-intervention-posttest design including three phases of research activities In Phase 1 pretest the investigators will administer a large battery of outcome measures including physical psychological emotional and cognitive and social function measures to assess the baseline performance The data collected at pretest also addresses the first sub-objective to identify sociodemographic risk predictors for the biopsychosocial functions and resilience among Chinese older immigrants in Canada In Phase 2 intervention participants will be randomly assigned to an active aging with resilience an active aging and a workshop control condition They will go through 4 weeks of 8 sessions of trainingcontrol treatment delivered virtually through ZoomYouTube and 8 sessions of offline self-practice In Phase 3 posttest all participants who completed the intervention programs will complete the same battery of the outcome measures as administered at the pretest session Their performance on the outcome measures at posttest will be compared against pretest to evaluate the efficacy of the training programs
Intervention
The virtually-delivered intervention program will be developed based on previous studies and practices that proved to be effective in resilience-building and active
During the 4-week training period delivered through ZoomYouTube participants in the active aging with resilience group will complete 8 sessions approximately 15 hours per session and 2 sessions per week of active aging training program integrated with a resilience-building module Each session will start with a 15-min session of resilience building activities modified from positive psychology resilience-building activities that promotes various resilience characters eg gratitude forgiveness grit etc This will be followed by the 1-hour multi-dimensional active aging training activities including progressive aging in motion physical and nutrition training eg age-appropriate Choose to move physical workout on-line videos cognitive training with executive function and speed based on a customized module on CogniFit website socialization and social engagement eg discussion on the topic and session followed by homework on volunteering calling friendsfamilies community activity participation etc and combined bio-psycho-social multi-component training eg performing a cognitive tasks such as counting backwards or memorizing names while doing physical exercise in a virtual socialization setting Participants in the active aging group will receive the same training except that the initial 15-min resilience-building activities will be replaced by warmup activities such as watching some pre-selected video on active aging and completing a quiz afterwards Both the active aging with resilience and traditional active aging group will also engage in 8 offline practice sessions where they follow instructions to practice and repeat the last completed modules Finally participants in the receptive workshop control group will attend 8 virtual workshops or watching workshop videos following the same 4-week schedule as the two training groups on different aging-related topics such as physical health mental health cognitive wellbeing emotional regulation social engagement and resilience Each workshop will take approximately 15 hours including 30 min for questions They will also review and watch the replays of last workshops and take a short survey question after each review session All these activities will be delivered virtually via ZoomYouTube in groups of 10-15 individuals
Data Analysis Plan To identify active aging and resilience predictors a set of explorative multivariate linear regression models will be conducted on the data collected at the pretest session with all sociodemographic as predictors and outcome measure performance as dependent variables To evaluate the relative efficacy of the active aging intervention programs a 3 condition by 2 session mixed model analysis of variances ANOVA models will be conducted on each outcome variable after controlling for potential sociodemographic covariates For comparison and clarity purposes if the outcome measures within each function domain demonstrates similar patterns the investigators will calculate a composite outcome variable based on the z-scores of all involved measures to index the performance level of that specific functional domain This composite score will be used as the outcome variable in the ANOVA In light of the literature the investigators hypothesized that the active aging with resilience training will produce larger and wider benefits relative to the active aging training both compared against the receptive workshop control condition
1 to develop a multi-domain digital active aging training program through Zoom to promote active aging and
2 to evaluate whether adding a resilience-building module would enhance the active aging training efficacy to mitigate the lingering detrimental impacts of the pandemic
Sample
For Study 1 the investigators will recruit 120 Mandarin-speaking healthy older Chinese immigrants aged 60 Chinese migrants through WeChata popular instant messaging app among Chineseemaillab website social media channels eg Facebook Twitter from the community partners see a list attached For Study 2 we will recruit 120 English-speaking healthy White Canadian older adults aged 60 through TMSPSS the senior participant pool at Toronto Metropolitan University or advertisements
Overall Design and Procedure
Informed consent will be collected The proposed study will take a traditional pretest-intervention-posttest design including three phases of research activities In Phase 1 pretest the investigators will administer a large battery of outcome measures including physical psychological emotional and cognitive and social function measures to assess the baseline performance The data collected at pretest also addresses the first sub-objective to identify sociodemographic risk predictors for the biopsychosocial functions and resilience among Chinese older immigrants in Canada In Phase 2 intervention participants will be randomly assigned to an active aging with resilience an active aging and a workshop control condition They will go through 4 weeks of 8 sessions of trainingcontrol treatment delivered virtually through ZoomYouTube and 8 sessions of offline self-practice In Phase 3 posttest all participants who completed the intervention programs will complete the same battery of the outcome measures as administered at the pretest session Their performance on the outcome measures at posttest will be compared against pretest to evaluate the efficacy of the training programs
Intervention
The virtually-delivered intervention program will be developed based on previous studies and practices that proved to be effective in resilience-building and active
During the 4-week training period delivered through ZoomYouTube participants in the active aging with resilience group will complete 8 sessions approximately 15 hours per session and 2 sessions per week of active aging training program integrated with a resilience-building module Each session will start with a 15-min session of resilience building activities modified from positive psychology resilience-building activities that promotes various resilience characters eg gratitude forgiveness grit etc This will be followed by the 1-hour multi-dimensional active aging training activities including progressive aging in motion physical and nutrition training eg age-appropriate Choose to move physical workout on-line videos cognitive training with executive function and speed based on a customized module on CogniFit website socialization and social engagement eg discussion on the topic and session followed by homework on volunteering calling friendsfamilies community activity participation etc and combined bio-psycho-social multi-component training eg performing a cognitive tasks such as counting backwards or memorizing names while doing physical exercise in a virtual socialization setting Participants in the active aging group will receive the same training except that the initial 15-min resilience-building activities will be replaced by warmup activities such as watching some pre-selected video on active aging and completing a quiz afterwards Both the active aging with resilience and traditional active aging group will also engage in 8 offline practice sessions where they follow instructions to practice and repeat the last completed modules Finally participants in the receptive workshop control group will attend 8 virtual workshops or watching workshop videos following the same 4-week schedule as the two training groups on different aging-related topics such as physical health mental health cognitive wellbeing emotional regulation social engagement and resilience Each workshop will take approximately 15 hours including 30 min for questions They will also review and watch the replays of last workshops and take a short survey question after each review session All these activities will be delivered virtually via ZoomYouTube in groups of 10-15 individuals
Data Analysis Plan To identify active aging and resilience predictors a set of explorative multivariate linear regression models will be conducted on the data collected at the pretest session with all sociodemographic as predictors and outcome measure performance as dependent variables To evaluate the relative efficacy of the active aging intervention programs a 3 condition by 2 session mixed model analysis of variances ANOVA models will be conducted on each outcome variable after controlling for potential sociodemographic covariates For comparison and clarity purposes if the outcome measures within each function domain demonstrates similar patterns the investigators will calculate a composite outcome variable based on the z-scores of all involved measures to index the performance level of that specific functional domain This composite score will be used as the outcome variable in the ANOVA In light of the literature the investigators hypothesized that the active aging with resilience training will produce larger and wider benefits relative to the active aging training both compared against the receptive workshop control condition
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