HLTH 6246 Week 10 Fall Concern Study Proposal Draft Example

Proposal Draft: Does an Eight-Session Fear of Falling Education Series at County Senior Centers Reduce Concern About Falling and Activity Restriction Among Adults 60 and Older? A Waitlist Design Traced Back to the Question at Every Step

Student Name

Walden University

HLTH 6246: Introduction to Research in Health and Wellness Education

Instructor Name

Month Day, Year

Proposal Draft: Does an Eight-Session Fear of Falling Education Series at County Senior Centers Reduce Concern About Falling and Activity Restriction Among Adults 60 and Older? A Waitlist Design Traced Back to the Question at Every Step

Problem

Falls are common and costly among older adults. In 2020, more than one in four Americans past 65 said they had fallen within the previous 12 months, women (28.9%) slightly more often than men (26.1%); in 2021, unintentional falls caused 38,742 deaths in this age group, or 78.0 per 100,000 people (Kakara et al., 2023). Fear of falling compounds the risk. Older adults who fear falling often limit their activity, losing strength and balance and becoming more likely to fall. Senior centers in many counties offer group education intended to reduce that fear, but the centers rarely evaluate whether participants' concern or activity actually change.

Purpose

This study aims to estimate whether an eight-session group education series on fear of falling, delivered at county senior centers by trained volunteer leaders, reduces participants' concern about falling and activity restriction compared with waiting for the series.

Research Question

Among adults aged 60 and older who enroll at participating senior centers in one county, is concern about falling, measured by the Falls Efficacy Scale-International, lower eight weeks after enrollment among those who receive the eight-session series than among those placed on a waitlist?

Three features of the question shape everything below. It names a comparison, series against waitlist, so the design needs a comparison group. It names change over a fixed period, eight weeks, so the design needs measurement before and after. And it names a specific instrument, so the measures section must justify that instrument.

Design

The study is a randomized waitlist design at the individual level within senior centers. Each enrolled participant is randomly assigned to start the series in the current session or to wait for the next session, which begins after the eight-week measurement. Waitlist participants receive the series after their second measurement, so no one is denied it.

The design follows from the question's grammar. A comparison of two conditions requires assignment that makes them alike at the start, which randomization provides. Measuring both groups at baseline and at eight weeks allows the comparison to rest on change rather than on end points alone. A waitlist suits the setting because senior centers already run sessions in cycles and often have more interested members than places.

Randomizing individuals within centers carries a contamination risk, since waitlisted members may hear about the content from friends in the series. That risk is accepted here because the series' active ingredients are guided practice and group discussion, which are hard to pass on secondhand, and because the number of senior centers in one county is too small to randomize centers with adequate power. The study will ask waitlisted participants at eight weeks whether they discussed the series with participants, so the extent of contamination can be reported.

The series itself follows the model of a group program shown in a randomized trial to increase intended activity and mobility control immediately after the intervention, with effects that diminished over time without a booster (Tennstedt et al., 1998), and later adapted for delivery by volunteer lay leaders (Healy et al., 2008).

Sampling

Population: adults aged 60 and older who are members of the county's senior centers. Eligibility: reports at least some concern about falling on a screening question, can walk with or without an aid, and can attend sessions in person. Exclusions: residents of nursing facilities, who live in a different environment, and people unable to complete the questionnaire in English or Spanish even with help, because the instrument versions available to the study are in those languages.

Planned size: about 160 participants, 80 per arm, across four senior centers over two enrollment cycles. That number is planned to detect a moderate difference in concern scores while allowing for roughly 15% loss by eight weeks; the final calculation will use variance estimates from published studies of the instrument.

Recruitment: center staff will announce the series at activities and in newsletters, and volunteers will hold sign-up tables at meal programs. Each person who signs up will be screened, consented and randomized by a staff member who does not deliver the series.

Measures

Primary outcome: concern about falling, measured by the Falls Efficacy Scale-International, a 16-item instrument developed with 704 adults aged 60 to 95 that showed excellent internal consistency and test-retest reliability (Yardley et al., 2005). It fits the question because it asks about concern across both easy activities at home and demanding activities outside, which is where activity restriction appears.

Secondary outcomes: self-reported activity restriction due to concern about falling, measured with a short set of items asking whether the participant has avoided specific activities in the past four weeks; and falls, recorded by participants on a monthly calendar. Falls are secondary because an eight-week window is too short to show a difference in an event this variable.

Measurement points: baseline before randomization and eight weeks later, administered by staff who do not know the participant's assignment.

Analysis Plan

The primary analysis will compare eight-week concern scores between arms, adjusting for baseline scores and senior center. Participants will be analyzed in the arm to which they were assigned, whatever their attendance. Attendance will be described for the series arm, and a secondary analysis will examine whether participants who attended at least six of eight sessions differ, with the caution that attendance is not randomized.

Protections

An institutional review board must approve the study before recruitment begins. Participants will give written informed consent. Questionnaires will be identified by number only. Participants who report a fall with injury during the study will be encouraged to contact their health care provider, and staff will follow the centers' existing procedures for falls on site.

Limits

The study measures change at eight weeks, so it cannot say whether reductions in concern last; the earlier trial's diminishing effects suggest they may fade without booster sessions (Tennstedt et al., 1998). Participants are volunteers at senior centers, who may be more socially active than older adults who never attend one. Concern about falling is self-reported, and participants who know their assignment may answer accordingly.

References

Healy, T. C., Peng, C., Haynes, M. S., McMahon, E. M., Botler, J. L., & Gross, L. (2008). The feasibility and effectiveness of translating A Matter of Balance into a volunteer lay leader model. Journal of Applied Gerontology, 27(1), 34-51. https://doi.org/10.1177/0733464807308620

Kakara, R., Bergen, G., Burns, E., & Stevens, M. (2023). Nonfatal and fatal falls among adults aged 65 years and older, United States, 2020-2021. Morbidity and Mortality Weekly Report, 72(35), 938-943. https://doi.org/10.15585/mmwr.mm7235a1

Tennstedt, S., Howland, J., Lachman, M., Peterson, E., Kasten, L., & Jette, A. (1998). A randomized, controlled trial of a group intervention to reduce fear of falling and associated activity restriction in older adults. Journals of Gerontology Series B: Psychological Sciences and Social Sciences, 53(6), P384-P392. https://doi.org/10.1093/geronb/53B.6.P384

Yardley, L., Beyer, N., Hauer, K., Kempen, G., Piot-Ziegler, C., & Todd, C. (2005). Development and initial validation of the Falls Efficacy Scale-International (FES-I). Age and Ageing, 34(6), 614-619. https://doi.org/10.1093/ageing/afi196