AgingNCT03518580
Active Life Engagement in Relation to Health-related Outcomes Among Community-dwelling Chinese Older Adults
An observational study of Aging, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to examine within-person variations of different contexts (time, physical, psychosocial and affective) of active life engagement, and how these variations predict a set of physiological indicators and health-related outcomes among community-dwelling older people. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- real-time assessment of biopsychosocial functioning
- How many people
- 78 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Jul 2017to 5 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy aging population living in the urban areas of a site city, Changsha in the central part of China.
Who may be able to join
- aged between 50-70; lived in the community independently; volunteer to participate in this study
Who cannot join
- unable to complete brief survey presented in mobile devices (e.g., have severe visual deficits or other self-report difficulty reading the screen);
- diagnosed with a cognition disorder or a mental disorder (e.g., major depressive disorder);
- diagnosed with hypertension or history of chronic disease with a cardiovascular component (e.g., diabetes);
- use of cardiovascular prescription medication, consumption of more than 10 alcoholic beverages a week.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Ecological Momentary Assessment to Examine Within-person Variations in Daily Experiences of Active Life Engagement in Relation to Health-related Outcomes Among Community-dwelling Chinese Older Adults
This study aims to examine within-person variations of different contexts (time, physical, psychosocial and affective) of active life engagement, and how these variations predict a set of physiological indicators and health-related outcomes among community-dwelling older people. Specifically, this study has the following objectives.
Objective 1: To investigate within-person variations in different contexts (i.e., time, physical, psychosocial, and affective) of active life engagement and interactions of these contexts.
Read more
Objective 2: To examine how within-person variations in different contexts (i.e., time, physical, psychosocial, and affective) of active life engagement and interactions of these contexts may associate with a set of cardiovascular indicators measured on daily basis.
Objective 3: To examine how within-person variations in different contexts (i.e., time, physical, psychosocial, and affective) of active life engagement and interactions of these contexts may associate with a set of health-related outcomes (e.g., physical functioning, depression, health-related quality of life).
Read the detailed description
- Participants
This study will recruit 70 participants from the community with the help from staffs from community service center. Investigators recruited participants who aged 60 or older and lived in the community independently, and screened participants for eligibility based on the following exclusionary criteria: (1) unable to complete brief survey presented in mobile devices (e.g., have severe visual deficits or other self-report difficulty reading the screen), (2) diagnosed with a cognition disorder, (4) diagnosed with a mental disorder.
Study protocol
- Self-administered questionnaire survey
All the participants will be asked to complete the baseline self-administrated survey on line (in some cases, participants could be organized to complete the survey under the guide of the research staff).
II. Training sessions/orientation
All the eligible participants will be invited to attend the training session/orientation. The research staff will assign each participant a Android phone installed with a researcher-developed application and a mobile-electrocardiogram (ECG) recording device. The participants will be briefed on its basic functions and how to use the application and device to provide data. The whole session will take steps proactively to increase participants' confidence and comfort with using the electronic band and the real-time assessment application through in-person training and mutual support between participants. Detailed take-home handbook (hardcopy or electronic version) that cover the use guidelines of the electronic bans and the real-time assessment application, and troubleshooting help, will be distributed to participants. Then, two warm-up days prior to the main study will be conducted and on-call help will be provided.
III. Real-time assessment survey of daily experiences
The real-time assessment application will allow each user to register a personal account, and to define their person-specific time-frame for the procedure, in specific, the start and the end time in a typical day they accept the signaling. The time frame will basically cover the user's waking hours (approximately 7 ± 3 hours). Within the defined time frame, the mobile device with the application will randomly prompt the user to complete a report for 6 times. The minimum and the maximum time between two consecutive signals will be 30 and 150 minutes respectively. The device will correctly record each response time once sending the signal. If the device receives no response for over 20 minutes, substitute prompts will be automatically sent every 5 minutes for 2 times. If still no response, a missing will be recorded. This procedure will be repeated on 7 consecutive days, with different random patterns for each day. For answering one signaling report, it will take approximately 3 to 5 minutes for most users (a total of less than 30 min per day). The content of report will be the same each time, which will comprise questions on engagement in daily activities, individual distractions, mood, and social systems.
IV. Physiological data provision
Physiological data will be collected concurrently during the 7 consecutive days for real-time data collection. All participants will be required to carry the mobile-ECG device assigned to them during the whole process of data collection. They will use the smartphone-based application and the mobile-ECG device to provide a 30-second ECG recording for six times each day.
- In-person follow-up survey
All participants will be asked to complete the open-ended questions focusing on the feasibility/acceptability of the method.
No drug usage and medical treatment will be involved in the study. Intensive assessment do not impose any physical or medical risk to participants. The only possible problem is that the intensive assessment may interfere with the participants' normal daily routines. Participants can voluntarily drop out the study at any time, without giving any reason.
Data analyses:
Intra-individual variability in the activity engagement will be analyzed by calculating the standard-deviation for each participant's timing of each domains of engagement resulting in an intra-individual standard deviation (iSD). In order to model within-person change and between-person factors simultaneously, two alternative statistical methods, namely, time series analysis and random coefficient multilevel modelling will be used. Multiple hierarchical regression analyses will be conducted with activity indicators predicting health and well-being outcomes.
- Conditions
- Aging
- Being tested
- real-time assessment of biopsychosocial functioning
- Keywords
- mobile technology, real-time assessment, active life engagement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real-time assessment of biopsychosocial functioningOther
the participants were asked to provide biopsychosocial data using the mobile device
What is being measured
The primary outcome is the main question the study is designed to answer.
Momentary positive and negative emotion
The extent to which the participant feel happy, excited, calm, sad, anxious, irritated, sleepy, alert, quiet, and lonely at the assessment time (0 = not at all to 4 = very much).
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start2 Jul 2017
- Primary completion28 Feb 2018
- Study completion5 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Vivian W.Q. Lou, The University of Hong Kong
- Investigators
- Vivian Lou, PhD, Principal investigator, Sau Po Center on Ageing, HKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518580
- Sponsor's protocol ID
- EA1706016
- Status last verified
- May 2018
- First submitted
- 22 Mar 2018
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected in this study will be published and submitted to academic journals to share with other researchers.
Publications
Fang B, Li D, Chen B, Huang J, Hou Y, Liu H. Perceived Support Protects Against Negative Affective Experiences of Momentary Solitude: An Ecological Momentary Assessment Study. J Gerontol B Psychol Sci Soc Sci. 2022 Dec 29;77(12):2170-2181. doi: 10.1093/geronb/gbac081.
PubMed 35678188
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Ecological Momentary Assessment to Examine Within-person Variations in Daily Experiences of Active Life Engagement in Relation to Health-related Outcomes Among Community-dwelling Chinese Older Adults
- ClinicalTrials.gov ID
- NCT03518580
- Acronym / sponsor ID
- EA1706016
- Conditions
- Aging
- Keywords
- mobile technology, real-time assessment, active life engagement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 2 Jul 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 5 Mar 2018 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to examine within-person variations of different contexts (time, physical, psychosocial and affective) of active life engagement, and how these variations predict a set of physiological indicators and health-related outcomes among community-dwelling older people. Specifically, this study has the following objectives.
Objective 1: To investigate within-person variations in different contexts (i.e., time, physical, psychosocial, and affective) of active life engagement and interactions of these contexts.
Objective 2: To examine how within-person variations in different contexts (i.e., time, physical, psychosocial, and affective) of active life engagement and interactions of these contexts may associate with a set of cardiovascular indicators measured on daily basis.
Objective 3: To examine how within-person variations in different contexts (i.e., time, physical, psychosocial, and affective) of active life engagement and interactions of these contexts may associate with a set of health-related outcomes (e.g., physical functioning, depression, health-related quality of life).
Detailed description
- Participants
This study will recruit 70 participants from the community with the help from staffs from community service center. Investigators recruited participants who aged 60 or older and lived in the community independently, and screened participants for eligibility based on the following exclusionary criteria: (1) unable to complete brief survey presented in mobile devices (e.g., have severe visual deficits or other self-report difficulty reading the screen), (2) diagnosed with a cognition disorder, (4) diagnosed with a mental disorder.
Study protocol
- Self-administered questionnaire survey
All the participants will be asked to complete the baseline self-administrated survey on line (in some cases, participants could be organized to complete the survey under the guide of the research staff).
II. Training sessions/orientation
All the eligible participants will be invited to attend the training session/orientation. The research staff will assign each participant a Android phone installed with a researcher-developed application and a mobile-electrocardiogram (ECG) recording device. The participants will be briefed on its basic functions and how to use the application and device to provide data. The whole session will take steps proactively to increase participants' confidence and comfort with using the electronic band and the real-time assessment application through in-person training and mutual support between participants. Detailed take-home handbook (hardcopy or electronic version) that cover the use guidelines of the electronic bans and the real-time assessment application, and troubleshooting help, will be distributed to participants. Then, two warm-up days prior to the main study will be conducted and on-call help will be provided.
III. Real-time assessment survey of daily experiences
The real-time assessment application will allow each user to register a personal account, and to define their person-specific time-frame for the procedure, in specific, the start and the end time in a typical day they accept the signaling. The time frame will basically cover the user's waking hours (approximately 7 ± 3 hours). Within the defined time frame, the mobile device with the application will randomly prompt the user to complete a report for 6 times. The minimum and the maximum time between two consecutive signals will be 30 and 150 minutes respectively. The device will correctly record each response time once sending the signal. If the device receives no response for over 20 minutes, substitute prompts will be automatically sent every 5 minutes for 2 times. If still no response, a missing will be recorded. This procedure will be repeated on 7 consecutive days, with different random patterns for each day. For answering one signaling report, it will take approximately 3 to 5 minutes for most users (a total of less than 30 min per day). The content of report will be the same each time, which will comprise questions on engagement in daily activities, individual distractions, mood, and social systems.
IV. Physiological data provision
Physiological data will be collected concurrently during the 7 consecutive days for real-time data collection. All participants will be required to carry the mobile-ECG device assigned to them during the whole process of data collection. They will use the smartphone-based application and the mobile-ECG device to provide a 30-second ECG recording for six times each day.
- In-person follow-up survey
All participants will be asked to complete the open-ended questions focusing on the feasibility/acceptability of the method.
No drug usage and medical treatment will be involved in the study. Intensive assessment do not impose any physical or medical risk to participants. The only possible problem is that the intensive assessment may interfere with the participants' normal daily routines. Participants can voluntarily drop out the study at any time, without giving any reason.
Data analyses:
Intra-individual variability in the activity engagement will be analyzed by calculating the standard-deviation for each participant's timing of each domains of engagement resulting in an intra-individual standard deviation (iSD). In order to model within-person change and between-person factors simultaneously, two alternative statistical methods, namely, time series analysis and random coefficient multilevel modelling will be used. Multiple hierarchical regression analyses will be conducted with activity indicators predicting health and well-being outcomes.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy aging population living in the urban areas of a site city, Changsha in the central part of China.
Key inclusion criteria (1 listed)
- aged between 50-70; lived in the community independently; volunteer to participate in this study
Key exclusion criteria (4 listed)
- unable to complete brief survey presented in mobile devices (e.g., have severe visual deficits or other self-report difficulty reading the screen);
- diagnosed with a cognition disorder or a mental disorder (e.g., major depressive disorder);
- diagnosed with hypertension or history of chronic disease with a cardiovascular component (e.g., diabetes);
- use of cardiovascular prescription medication, consumption of more than 10 alcoholic beverages a week.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real-time assessment of biopsychosocial functioningthe participants were asked to provide biopsychosocial data using the mobile device | Other | – |
Primary outcome
Momentary positive and negative emotion
Time frame: one week
The extent to which the participant feel happy, excited, calm, sad, anxious, irritated, sleepy, alert, quiet, and lonely at the assessment time (0 = not at all to 4 = very much).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Derived from this study: PubMed 35678188Fang B, Li D, Chen B, Huang J, Hou Y, Liu H. Perceived Support Protects Against Negative Affective Experiences of Momentary Solitude: An Ecological Momentary Assessment Study. J Gerontol B Psychol Sci Soc Sci. 2022 Dec 29;77(12):2170-2181. doi: 10.1093/geronb/gbac081.
- Individual participant dataSharing planned: Yes. Data collected in this study will be published and submitted to academic journals to share with other researchers.
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivian Lou, PhD principal investigator
Sau Po Center on Ageing, HKU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Momentary positive and negative emotion (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03518580, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.