NCT06569576

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

1.2 years

First QC Date

August 19, 2024

Last Update Submit

August 23, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    up to 8 weeks

Secondary Outcomes (1)

  • Open ended interview

    up to 8 weeks

Study Arms (2)

in-person wellness program

EXPERIMENTAL

The program is delivered at the senior center site.

Behavioral: Wellness program

Online Wellness Program

EXPERIMENTAL

The program is delivered remotely. Participants join from their home environment.

Behavioral: Wellness program

Interventions

It combines seated yoga exercises, mindfulness, and social participation activities and discussions, and can be delivered in-person or via tele-health.

Online Wellness Programin-person wellness program

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mercy University

Dobbs Ferry, New York, 10522, United States

Location

MeSH Terms

Interventions

Health Promotion

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Comparing online delivery vs in-person delivery
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 26, 2024

Study Start

October 7, 2023

Primary Completion

December 30, 2024

Study Completion

December 30, 2025

Last Updated

August 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations