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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Hong Kong1 site
  • Sau Po Center on Ageing HKU

    Hong Kong

Other trials in Hong Kong

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
  1. 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

  1. 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.

  1. 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.

  1. 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.

  1. First posted8 May 2018
  2. Study start2 Jul 2017
  3. Primary completion28 Feb 2018
  4. Study completion5 Mar 2018

Resources

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)
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

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.

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