Power V360 - Promoting Optimal Wellness Among Elders Thro... | NCT03252262

Studies
Power V360 - Promoting Optimal Wellness Among Elders Through Vitalize 360

NCT03252262

Sponsor

Hebrew SeniorLife

Status

Completed

Last Update Posted

Aug 17, 2017Actual

Enrollment

161Actual

Phase

Not Applicable

Conditions

Health, Subjective

Interventions

Vitalize 360

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2014Actual

Primary Completion Date

Dec 30, 2015Actual

Completion Date

Dec 30, 2015Actual

First Submitted Date

Apr 12, 2017

First Submission Date that Met QC Criteria

Aug 14, 2017

First Posted Date

Aug 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2017

Last Update Posted Date

Aug 17, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

161Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Jack Satter House	Active Comparator	Residents of Jack Satter House who participated in the Vitalize 360 Program.	Other: Vitalize 360
Center Communities of Brookline	Active Comparator	Residents of Center Communities of Brookline who participated in the Vitalize 360 Program.	Other: Vitalize 360
Simon C. Fireman	Active Comparator	Residents of Simon C. Fireman who participated in the Vitalize 360 Program	Other: Vitalize 360

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitalize 360	Other	A comprehensive geriatric assessment system and wellness coaching program.	Center Communities of Brookline Jack Satter House Simon C. Fireman

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Physical Activity Level	number of hours engaged in physical activity over the past 3 days	18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 60 years and over, residing in subsidized housing sites operated by Hebrew SeniorLife and participating in Vitalize 360 program

Exclusion Criteria:

younger than 60 years, not participating in Vitalize 360 program and not a permanent resident of housing sites.

Accepts Healthy Volunteers

Yes

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth P Howard, PhD	Hebrew Rehabilitation Center	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Contact PI to obtain approval for use of COLLAGE/interRAI data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided