Health, SubjectiveNCT03252262
Power V360 - Promoting Optimal Wellness Among Elders Through Vitalize 360
A study testing Vitalize 360 in people with Health, Subjective, run by Hebrew SeniorLife.
Trial summary
The primary purpose of this project was to implement Vitalize 360, a comprehensive assessment system and wellness coaching program for vulnerable, low income, community dwelling older adults, and to determine if this program is effective in promoting and sustaining self-management skills to increase well-being and… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective
- What is being tested?
- Vitalize 360
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2014to 30 Dec 2015
- 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 60 years and older
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60 years and over, residing in subsidized housing sites operated by Hebrew SeniorLife and participating in Vitalize 360 program
Who cannot join
- younger than 60 years, not participating in Vitalize 360 program and not a permanent resident of housing sites.
About this study
The primary purpose of this project was to implement Vitalize 360, a comprehensive assessment system and wellness coaching program for vulnerable, low income, community dwelling older adults, and to determine if this program is effective in promoting and sustaining self-management skills to increase well-being and functional health among this group. Designed specifically for community-dwelling older adults, Vitalize 360 provides a unique opportunity to guide elders in selecting personal goals that align with their assessment results and develop an action plan for goal achievement. This strategy holds potential as an effective mechanism to empower elders to implement behaviors that promote healthy aging.
Read the detailed description
The purpose of this project was to determine if Vitalize 360, a comprehensive assessment system and wellness coaching program was effective in promoting and sustaining increased physical activity and improved mood, health status and quality of life. A repeated measures, secondary analysis design was the selected approach Data from 161 participants were used to test the hypotheses. After one year, the sample had improvement with increased socialization while physical activity level fluctuated over time suggestive of a seasonality effect. Paired t-tests and repeated measures analysis revealed no statistically significant improvement in physical activity level, mood, health status or quality of life. Vitalize 360 provides a unique opportunity to guide elders in selecting personal goals that align with their assessment results and develop an action plan for goal achievement. When used among vulnerable and frail elders, some modifications are needed to provide sustained, favorable outcomes.
- Conditions
- Health, Subjective
- Being tested
- Vitalize 360
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitalize 360Other
A comprehensive geriatric assessment system and wellness coaching program.
| Study group | Role | What they receive |
|---|---|---|
| Jack Satter House | Active comparator | Residents of Jack Satter House who participated in the Vitalize 360 Program. Receives: Other: Vitalize 360 |
| Center Communities of Brookline | Active comparator | Residents of Center Communities of Brookline who participated in the Vitalize 360 Program. Receives: Other: Vitalize 360 |
| Simon C. Fireman | Active comparator | Residents of Simon C. Fireman who participated in the Vitalize 360 Program Receives: Other: Vitalize 360 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Level
number of hours engaged in physical activity over the past 3 days
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start30 Jan 2014
- Primary completion30 Dec 2015
- Study completion30 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health, SubjectiveStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth P Howard, PhD, Principal investigator, Hebrew Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252262
- Sponsor's protocol ID
- P 30 AG048785
- Status last verified
- Apr 2017
- First submitted
- 12 Apr 2017
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Contact PI to obtain approval for use of COLLAGE/interRAI data
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Power V360 - Promoting Optimal Wellness Among Elders Through Vitalize 360
- ClinicalTrials.gov ID
- NCT03252262
- Acronym / sponsor ID
- P 30 AG048785
- Conditions
- Health, Subjective
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Study start
- 30 Jan 2014 (actual)
- Primary completion
- 30 Dec 2015 (actual)
- Study completion
- 30 Dec 2015 (actual)
- First posted
- 17 Aug 2017 (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.
The primary purpose of this project was to implement Vitalize 360, a comprehensive assessment system and wellness coaching program for vulnerable, low income, community dwelling older adults, and to determine if this program is effective in promoting and sustaining self-management skills to increase well-being and functional health among this group. Designed specifically for community-dwelling older adults, Vitalize 360 provides a unique opportunity to guide elders in selecting personal goals that align with their assessment results and develop an action plan for goal achievement. This strategy holds potential as an effective mechanism to empower elders to implement behaviors that promote healthy aging.
Detailed description
The purpose of this project was to determine if Vitalize 360, a comprehensive assessment system and wellness coaching program was effective in promoting and sustaining increased physical activity and improved mood, health status and quality of life. A repeated measures, secondary analysis design was the selected approach Data from 161 participants were used to test the hypotheses. After one year, the sample had improvement with increased socialization while physical activity level fluctuated over time suggestive of a seasonality effect. Paired t-tests and repeated measures analysis revealed no statistically significant improvement in physical activity level, mood, health status or quality of life. Vitalize 360 provides a unique opportunity to guide elders in selecting personal goals that align with their assessment results and develop an action plan for goal achievement. When used among vulnerable and frail elders, some modifications are needed to provide sustained, favorable outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Jack Satter House | Active comparator | Other: Vitalize 360Residents of Jack Satter House who participated in the Vitalize 360 Program. |
| Center Communities of Brookline | Active comparator | Other: Vitalize 360Residents of Center Communities of Brookline who participated in the Vitalize 360 Program. |
| Simon C. Fireman | Active comparator | Other: Vitalize 360Residents of Simon C. Fireman who participated in the Vitalize 360 Program |
Who may qualify
- Ages
- 60 years and older
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 60 years and over, residing in subsidized housing sites operated by Hebrew SeniorLife and participating in Vitalize 360 program
Key exclusion criteria (1 listed)
- younger than 60 years, not participating in Vitalize 360 program and not a permanent resident of housing sites.
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 |
|---|---|---|
| Vitalize 360A comprehensive geriatric assessment system and wellness coaching program. | Other | Center Communities of Brookline, Jack Satter House, Simon C. Fireman |
Primary outcome
Physical Activity Level
Time frame: 18 months
number of hours engaged in physical activity over the past 3 days
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 17 Aug 2017.
- Individual participant dataSharing planned: Yes. Contact PI to obtain approval for use of COLLAGE/interRAI data
Related trials for Health, Subjective
RecruitingObservational study
Fuzhou Aging Brain Health Initiative
Dementia, Alzheimer Dementia (AD)
Recruiting
Exercise in Perimenopause to Improve Cognitive Health
Perimenopause, Subjective Cognitive Complaints
Recruiting
Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study
Healthy Participants, Healthy Adult Subject
Recruiting
Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Acute Postprandial Study
Healthy Participants, Healthy Adult Subject
Recruiting
Florida Community-Engaged Research Alliance (FL-CEAL)
Health, Subjective
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.
Elizabeth P Howard, PhD principal investigator
Hebrew Rehabilitation Center
Questions about this trial
What is this clinical trial studying?
A study testing Vitalize 360 in people with Health, Subjective, run by Hebrew SeniorLife.
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 1 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 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Physical Activity Level (time frame: 18 months). 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 17 Aug 2017.