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Bingocize: A Novel Mobile Application for Older Adult Health (Bingocize)

Primary Purpose

Activities of Daily Living, Accidental Fall, Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Socially-Based Exercise Intervention for Older Adults
Sponsored by
Western Kentucky University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Activities of Daily Living

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Normal or corrected normal vision
  • Mobility (i.e., not wheelchair bound)
  • English is native language
  • Minimum physical standards (e.g., ability to walk at least 10 meters)
  • No structured physical activity programs >150 minutes/week in last 6 months

Exclusion Criteria:

  • Severe neurological impairments (e.g., Parkinson's)
  • Colorblindness
  • Dementia

Sites / Locations

  • Webster County Senior Center
  • Chester County Senior Center
  • Johnson County Senior Center
  • Scotts Hill Senior Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

No Intervention

Arm Label

Exercise + Health Education + Bingo

Exercise + Bingo

Health Education + Bingo

Bingo Only

Arm Description

Socially-Based Exercise Intervention for Older Adults. Participants use the Bingocize app incorporating exercises AND health information on fall risks + diet/nutrition.

Socially-Based Exercise Intervention for Older Adults. Participants use the Bingocize app incorporating exercises ONLY.

Socially-Based Exercise Intervention for Older Adults. Participants use the Bingocize app incorporating health information on fall risks + diet/nutrition ONLY.

Participants use the Bingocize app to play bingo only.

Outcomes

Primary Outcome Measures

Changes in Executive Function - Inhibition Measure 1
Flanker Task
Changes in Executive Function - Updating
Dot Counting Task
Changes in Executive Function - Shifting
Set Shifting Task
Changes in Executive Function - Fluency
Phonemic and Category Fluency Tasks
Change in lower-body muscular strength
30-second chair stands
Change in dynamic balance
360 degree turns & Timed Up-And-Go
Changes in Executive Function - Inhibition Measure 2
Continuous Performance Task

Secondary Outcome Measures

Changes in Knowledge of Fall Risks and Proper Diet/Nutrition
Multiple-choice questions covering: recognition of health terms, weight management, proper diet, bone health, environmental fall risks, careful movement
Changes in upper body muscular strength
Grip strength tests
Changes in Fall Efficacy
Self-report scale assessing confidence in activities that may be perceived as having risk for falling
Changes in Dietary Habits
Dietary Screener Questionnaire (DSQ) assessing nutritional intake over past 30 days
Changes in Quality of Life
CDC Health related quality of life measure
Changes in Weight
Weight calculated by scale measurement
Changes in Blood Pressure
Blood pressure calculated by sphygmomanometer

Full Information

First Posted
August 6, 2018
Last Updated
September 2, 2022
Sponsor
Western Kentucky University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03629912
Brief Title
Bingocize: A Novel Mobile Application for Older Adult Health
Acronym
Bingocize
Official Title
Bingocize: A Novel Mobile Application to Help Maintain or Improve Older Adults' Health, Function, and Cognition
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 13, 2018 (Actual)
Primary Completion Date
May 13, 2022 (Actual)
Study Completion Date
May 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Kentucky University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study tests the effectiveness of using a new mobile application (Bingocize®) to improve older adults' (a) adherence to an engaging exercise program, and (b) aspects of functional performance, health knowledge, dietary habits, and cognition.
Detailed Description
Health-promoting interventions designed to improve physical and mental fitness can help reduce health care costs; they can also help maintain, or even improve, older adults' quality of life. However, getting older adults to adhere to health-promoting exercise interventions remains difficult because such programs are often perceived as being time-consuming, painful, or unenjoyable. The present study's objective is to investigate the effectiveness of a novel technological exercise intervention program for older adults (Bingocize); in doing so, the program has the potential to improve older adults' independence and quality of life. Older adults will participate in a pre/post-intervention design with random assignment to either the experimental or one of three comparison/control groups; each group will play Bingocize in a social setting with other older adults. Participants in the experimental group will use the app to engage in twice-weekly Bingocize sessions for twelve weeks (i.e., Bingo+Exercise+Health Education); control groups will also use the app for twelve weeks but for either health education-only, exercise-only, or bingo-only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Activities of Daily Living, Accidental Fall, Sarcopenia, Arteriosclerosis, Diabetes Mellitus, Type 2, Hypertension, Cognitive Decline, Executive Function, Cognitive Aging

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In each wave of the study (14 weeks per wave), participant groups are randomly assigned to one of four conditions (A,B,C,D). Condition A receives exercise + health education. Condition B receives exercise only. Condition C receives health education only. Condition D receives nothing.
Masking
None (Open Label)
Masking Description
Staff collecting pre- and post-intervention data are masked to participant condition.
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise + Health Education + Bingo
Arm Type
Experimental
Arm Description
Socially-Based Exercise Intervention for Older Adults. Participants use the Bingocize app incorporating exercises AND health information on fall risks + diet/nutrition.
Arm Title
Exercise + Bingo
Arm Type
Active Comparator
Arm Description
Socially-Based Exercise Intervention for Older Adults. Participants use the Bingocize app incorporating exercises ONLY.
Arm Title
Health Education + Bingo
Arm Type
Active Comparator
Arm Description
Socially-Based Exercise Intervention for Older Adults. Participants use the Bingocize app incorporating health information on fall risks + diet/nutrition ONLY.
Arm Title
Bingo Only
Arm Type
No Intervention
Arm Description
Participants use the Bingocize app to play bingo only.
Intervention Type
Behavioral
Intervention Name(s)
Socially-Based Exercise Intervention for Older Adults
Other Intervention Name(s)
Bingocize
Intervention Description
A socially-based app that incorporates exercise and/or health education into a format familiar and engaging to older adults, designed to improve adherence to health-promoting behaviors
Primary Outcome Measure Information:
Title
Changes in Executive Function - Inhibition Measure 1
Description
Flanker Task
Time Frame
Baseline and 12 Weeks
Title
Changes in Executive Function - Updating
Description
Dot Counting Task
Time Frame
Baseline and 12 Weeks
Title
Changes in Executive Function - Shifting
Description
Set Shifting Task
Time Frame
Baseline and 12 Weeks
Title
Changes in Executive Function - Fluency
Description
Phonemic and Category Fluency Tasks
Time Frame
Baseline and 12 Weeks
Title
Change in lower-body muscular strength
Description
30-second chair stands
Time Frame
Baseline and 12 Weeks
Title
Change in dynamic balance
Description
360 degree turns & Timed Up-And-Go
Time Frame
Baseline and 12 Weeks
Title
Changes in Executive Function - Inhibition Measure 2
Description
Continuous Performance Task
Time Frame
Baseline and 12 Weeks
Secondary Outcome Measure Information:
Title
Changes in Knowledge of Fall Risks and Proper Diet/Nutrition
Description
Multiple-choice questions covering: recognition of health terms, weight management, proper diet, bone health, environmental fall risks, careful movement
Time Frame
Baseline and 12 Weeks
Title
Changes in upper body muscular strength
Description
Grip strength tests
Time Frame
Baseline and 12 Weeks
Title
Changes in Fall Efficacy
Description
Self-report scale assessing confidence in activities that may be perceived as having risk for falling
Time Frame
Baseline and 12 Weeks
Title
Changes in Dietary Habits
Description
Dietary Screener Questionnaire (DSQ) assessing nutritional intake over past 30 days
Time Frame
Baseline and 12 Weeks
Title
Changes in Quality of Life
Description
CDC Health related quality of life measure
Time Frame
Baseline and 12 Weeks
Title
Changes in Weight
Description
Weight calculated by scale measurement
Time Frame
Baseline and 12 Weeks
Title
Changes in Blood Pressure
Description
Blood pressure calculated by sphygmomanometer
Time Frame
Baseline and 12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Normal or corrected normal vision Mobility (i.e., not wheelchair bound) English is native language Minimum physical standards (e.g., ability to walk at least 10 meters) No structured physical activity programs >150 minutes/week in last 6 months Exclusion Criteria: Severe neurological impairments (e.g., Parkinson's) Colorblindness Dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew C Shake, PhD
Organizational Affiliation
Western Kentucky University and Center for Applied Science in Health and Aging
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jason Crandall, PhD
Organizational Affiliation
Western Kentucky University and Center for Applied Science in Health and Aging
Official's Role
Principal Investigator
Facility Information:
Facility Name
Webster County Senior Center
City
Dixon
State/Province
Kentucky
ZIP/Postal Code
42409
Country
United States
Facility Name
Chester County Senior Center
City
Henderson
State/Province
Tennessee
ZIP/Postal Code
38340
Country
United States
Facility Name
Johnson County Senior Center
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
Scotts Hill Senior Center
City
Scotts Hill
State/Province
Tennessee
ZIP/Postal Code
38374
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available.
IPD Sharing Time Frame
Data will be available within 6 months after publication, and will remain available for a period of at least 3 years following completion of the clinical trial.
IPD Sharing Access Criteria
Investigators whose proposed use of the data has been approved by the Principal Investigators of the clinical trial.
IPD Sharing URL
http://www.wku.edu/casha
Links:
URL
http://www.wku.edu/casha
Description
Link to Center for Applied Science in Health & Aging

Learn more about this trial

Bingocize: A Novel Mobile Application for Older Adult Health

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