Group MeetingsNCT06569576
Promoting Aging in Place Through A Wellness Program
A study testing Wellness program in people with Group Meetings and Telehealth, run by Mercy University at 1 site in United States.
Trial summary
Study explores the impact of an eight-week Healthy Aging Wellness (HAW) group-based program delivered online and in-person to improve hope and well-being in community-dwelling older adults. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Group Meetings, Telehealth
- What is being tested?
- Wellness program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2023to 30 Dec 2025
- Phase
- Interventional
- 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 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years old or older
- independent in everyday life
- living at home
- Mini-Mental State Examination (MMSE) > 26
- English speakers
- access to a device with a camera and reliable internet services if they were recruited for the tele-health group
- health status verified by primary care physician.
Who cannot join
- balance issues
- history of falls within the last 6 months
- medical conditions considered contra-indications to exercise
- cognitive impairments, which may make participation in the program unsafe.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Aging in Place Through A Wellness Program: Comparing In-person and Online Delivery
Study explores the impact of an eight-week Healthy Aging Wellness (HAW) group-based program delivered online and in-person to improve hope and well-being in community-dwelling older adults.
Read the detailed description
Study explores the impact of an eight-week Healthy Aging Wellness (HAW) group-based program delivered online and in-person to improve hope and well-being in community-dwelling older adults. This study explores the implementation of the Healthy Aging Wellness program to support aging in place of community-dwelling older adults. It combines seated yoga exercises, mindfulness, and social activities.
- Conditions
- Group Meetings, Telehealth
- Being tested
- Wellness program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness programBehavioural
It combines seated yoga exercises, mindfulness, and social participation activities and discussions, and can be delivered in-person or via tele-health.
| Study group | Role | What they receive |
|---|---|---|
| in-person wellness program | Experimental | The program is delivered at the senior center site. Receives: Behavioral: Wellness program |
| Online Wellness Program | Experimental | The program is delivered remotely. Participants join from their home environment. Receives: Behavioral: Wellness program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrative Hope Scale (IHS)
- Self-measure of person's sense of hope
- Scored on a scale ranging from 1 (low) to 6 (high) points
- Total score ranges from 23 to138
Measured: up to 8 weeks
Personal Wellbeing Index: 5th Edition
- Self-measure of person's sense of wellbeing
- Scale from 0-10
- higher number indicates greater satisfaction
Measured: up to 8 weeks
Secondary outcomes (1)
Open ended interview
Interviewing individuals about their experience in the program
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start7 Oct 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Group MeetingsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Comparing online delivery vs in-person delivery
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mercy University
- Sponsor type
- University, hospital or other
- Collaborators
- Yeshiva University
- Responsible party
- Principal investigator, Jeanine, Mercy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569576
- Sponsor's protocol ID
- 20-57
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Aging in Place Through A Wellness Program: Comparing In-person and Online Delivery
- ClinicalTrials.gov ID
- NCT06569576
- Acronym / sponsor ID
- 20-57
- Conditions
- Group Meetings, Telehealth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mercy UniversityUniversity, hospital or other
- Collaborators
- Yeshiva University
- Study start
- 7 Oct 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 26 Aug 2024 (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.
Study explores the impact of an eight-week Healthy Aging Wellness (HAW) group-based program delivered online and in-person to improve hope and well-being in community-dwelling older adults.
Detailed description
Study explores the impact of an eight-week Healthy Aging Wellness (HAW) group-based program delivered online and in-person to improve hope and well-being in community-dwelling older adults. This study explores the implementation of the Healthy Aging Wellness program to support aging in place of community-dwelling older adults. It combines seated yoga exercises, mindfulness, and social activities.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparing online delivery vs in-person delivery
| Arm | Type | Receives |
|---|---|---|
| in-person wellness program | Experimental | Behavioral: Wellness programThe program is delivered at the senior center site. |
| Online Wellness Program | Experimental | Behavioral: Wellness programThe program is delivered remotely. Participants join from their home environment. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 65 years old or older
- independent in everyday life
- living at home
- Mini-Mental State Examination (MMSE) > 26
- English speakers
Key exclusion criteria (4 listed)
- balance issues
- history of falls within the last 6 months
- medical conditions considered contra-indications to exercise
- cognitive impairments, which may make participation in the program unsafe.
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 |
|---|---|---|
| Wellness programIt combines seated yoga exercises, mindfulness, and social participation activities and discussions, and can be delivered in-person or via tele-health. | Behavioural | Online Wellness Program, in-person wellness program |
Primary outcome
Integrative Hope Scale (IHS)
Time frame: up to 8 weeks
* Self-measure of person's sense of hope * Scored on a scale ranging from 1 (low) to 6 (high) points * Total score ranges from 23 to138
Personal Wellbeing Index: 5th Edition
Time frame: up to 8 weeks
* Self-measure of person's sense of wellbeing * Scale from 0-10 * higher number indicates greater satisfaction
1 secondary outcome
Open ended interview
Time frame: up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness program in people with Group Meetings and Telehealth, run by Mercy University at 1 site in United States.
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 7 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: status not confirmed, as of the sponsor's last update on 27 Aug 2024. 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 United States. 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?
Results are not available in the source record.
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?
Integrative Hope Scale (IHS) (time frame: up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2024.