Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
BMC Geriatrics
Published in: BMC Geriatrics 1/2017

Open Access 01-12-2017 | Study protocol

Protocol for the home hazards removal program (HARP) study: a pragmatic, randomized clinical trial and implementation study

Authors: Susan Stark, Emily Somerville, Marian Keglovits, Jane Conte, Melody Li, Yi-Ling Hu, Yan Yan

Published in: BMC Geriatrics | Issue 1/2017

Login to get access

Abstract

Background

Falls remain the leading cause of injury, long-term disability, premature institutionalization, and injury-related mortality in the older adult population. Home modifications, when delivered by occupational therapists, can reduce falls among high-risk community-dwelling older adults by 39%. However, home-modification implementation is not standard practice in the United States. The goal of the Home Hazard Removal Program (HARP) study is to implement an evidence-based home modification intervention for older adults designed to reduce the incidence of falls through an aging services network.

Methods

We will conduct a hybrid effectiveness/implementation trial of 300 older adults at risk for a fall who are randomized and followed for 12 months. Participants who are randomized to treatment will receive the home modification intervention provided by an occupational therapist in addition to usual care, defined as continued services from the area agency on aging. We will compare the effectiveness of the program and usual care using survival analysis with the time to the first fall over 12 months as the primary outcome of interest. Secondary outcomes include daily activity performance, fall self-efficacy, and health-related quality of life. Fidelity, dose, adherence, safety, cost, and health care utilization will also be examined in the implementation component of this study.

Discussion

This intervention targets an underserved, difficult to reach population of older adults. The tailored approach of the study intervention is a strength in improving adherence, as each recommendation is individualized to be acceptable to the participant. The effectiveness/implementation design of the study allows for rapid dissemination of results and implementation of the intervention in a United States social services agency.

Trial registration

Clinicaltrials.​gov identifier: NCT02392013. Retrospectively registered on March 5, 2015.
Literature
1.
Tinetti ME, Speechley M, Ginter SF. Risk factors for falls among elderly persons living in the community. N Engl J Med. 1988;319(26):1701–7.CrossRefPubMed
2.
Sattin RW, Rodriguez JG, DeVito CA, Wingo PA. Home environmental hazards and the risk of fall injury events among community-dwelling older persons. Study to assess falls among the elderly (SAFE) group. J Am Geriatr Soc. 1998;46(6):669–76.CrossRefPubMed
3.
Tinetti ME, Williams C. Falls, injuries due to falls, and the risk of admission to a nursing home. N Engl J Med. 1997;337(18):1279–84.CrossRefPubMed
4.
Sattin RW. Falls among older persons: a public health perspective. Annu Rev Public Health. 1992;13:489–508.CrossRefPubMed
5.
Sterling DA, O'Connor JA, Bonadies J. Geriatric falls: injury severity is high and disproportionate to mechanism. J Trauma Acute Care Surg. 2001;50(1):116–9.CrossRef
6.
Alexander BH, Rivara FP, Wolf ME. The cost and frequency of hospitalization for fall-related injuries in older adults. Am J Public Health. 1992;82(7):1020–3.CrossRefPubMedPubMedCentral
7.
Tinetti ME, Baker, D.I., McAvay G., Claus, E.B., Garret, P., Gottschalk M., et al. A multifactorial intervention to reduce the risk of falling among elderly people living in the community. N Engl J Med 1994;331(13):821-827.
8.
Arfken CL, Lach HW, Birge SJ, Miller JP. The prevalence and correlates of fear of falling in elderly persons living in the community. Am J Public Health. 1994;84(4):565–70.CrossRefPubMedPubMedCentral
9.
10.
Tromp AM, Pluijm SMF, Smit JH, Deeg DJH, Bouter LM, Lips P. Fall-risk screening test: A prospective study on predictors for falls in community-dwelling elderly. J Clin Epidemiol. 2001;54(8):837–44.
11.
Englander F, Hodson TJ, Terregrossa RA. The costs of fatal and nonfatal falls among older adults. Inj Prev. 2006;12:290–5.CrossRef
12.
Mahoney J, Sager M, Johnson J. Risk of falls after hospital discharge. J Am Geriatr Soc. 1994;42(3):269–74.CrossRefPubMed
13.
Nachreiner NM, Findorff MJ, Wyman JF, McCarthy TC. Circumstances and consequences of falls in community-dwelling older women. J Women's Health. 2007;16(10):1437–46.CrossRef
14.
Talbot L, Musiol R, Witham E, Metter EJ. Falls in young, middle-aged and older community dwelling adults: perceived cause, environmental factors and injury. BMC Public Health. 2005;5(1):86.CrossRefPubMedPubMedCentral
15.
Gill TM, Williams CS, Tinetti ME. Environmental hazards and the risk of nonsyncopal falls in the homes of community-living older persons. Med Care. 2000;38(12):1174–83.CrossRefPubMed
16.
17.
Clemson L, Mackenzie L, Ballinger C, Close JC, Cumming RG. Environmental interventions to prevent falls in community-dwelling older people: a meta-analysis of randomized trials. J Aging Health. 2008;20(8):954–71.CrossRefPubMed
18.
Carter SE, Campbell EM, Sanson-Fisher RW, Redman S, Gillespie WJ. Environmental hazards in the homes of older people. Age Ageing. 1997;26:195–202.CrossRefPubMed
19.
Stevens M, Holman CDA, Bennett N. Preventing falls in older people: impact of an intervention to reduce environmental hazards in the home. J Am Geriatr Soc. 2001;49:1442–7.CrossRefPubMed
20.
Nikolaus T. Preventing falls in community-dwelling frail older people using a home intervention team (HIT): results from the randomized falls HIT trial. J Am Geriatr Soc. 2003;51(3):300–5.CrossRefPubMed
21.
22.
Gitlin LN, Winter L, Dennis MP, Corcoran M, Schinfeld S, Hauck WW. A randomized trial of a multicomponent home intervention to reduce functional difficulties in older adults. J Am Geriatr Soc. 2006;54(5):809–16.CrossRefPubMed
23.
Stark S, Landsbaum A, Palmer J, Somerville E, Morris J. Home modifications improve daily activity performance of older adults. Can J Occup Ther. 2010;76:235–45.CrossRef
24.
Israel BA, Schulz AJ, Parker EA, Becker AB. Review of community-based research: assessing partnership approaches to improve public health. Annu Rev Public Health. 1998;19(1):173–202.CrossRefPubMed
25.
Satcher D, Israel BA, Eng E, Schulz AJ, Parker EA. Methods in community-based participatory research for health: Jossey-Bass; 2005.
26.
Minkler M, Wallerstein N. Community-based participatory research for health. San Francisco (CA): Jossey-Bass; 2003.
27.
28.
Branson RD, Davis Jr K, Butler KL. African Americans' participation in clinical research: importance, barriers, and solutions. Am J Surg. 2007;193(1):32–9.CrossRefPubMed
29.
Levkoff S, Sanchez H. Lessons learned about minority recruitment and retention from the centers on minority aging and health promotion. The Gerontologist. 2003;43(1):18–26.CrossRefPubMed
30.
Loftin WA, Barnett SK, Bunn PS, Sullivan P. Recruitment and retention of rural African Americans in diabetes research. Diab Educ. 2005;31(2):251–9.CrossRef
31.
Linnan L, Steckler A. Process evaluation for public health interventions and research: Jossey-Bass San Francisco, California; 2002.
32.
Show Me Falls Free Missouri Plan. An Action Plan for Preventing Falls Among Older Adults in the Community. In.: Missouri Department of Health and Senior Services; 2008.
33.
Close JCT, Lord SR, Antonova EJ, Martin M, Lensberg B, Taylor M, Hallen J, Kelly A. Older people presenting to the emergency department after a fall: a population with substantial recurrent healthcare use. Emerg Med J. 1999;29(9):742–7.CrossRef
34.
Albert M, McCaig LF, Ashman JJ. NCHS data brief emergency department visits by persons aged 65 and over: United States, 2009–2010. In., vol. 130. Atlanta: Centers for Disease Control and Prevention; 2013.
35.
Cumming R, Thomas M, Szonyi G, Salkeld G, O'Neill E, Westbury C, Frampton G. Home visits by an occupational therapist for assessment and modification of environmental hazards: a randomized trial of falls prevention. J Am Geriatr Soc. 1999;47:1397–402.CrossRefPubMed
36.
Katzman R, Brown T, Fuld P, et al. Validation of a short orientation memory concentration test of cognitive impairment. Am J Psychiatr. 1983;140:734–9.CrossRefPubMed
37.
Edwards DF, Baum CM, Meisel M, Depke M, Williams J, Braford T, Morrow-Howell N, Morris JC. Home-based multidisciplinary diagnosis and treatment of Inner-City elders with dementia. The Gerontologist. 1999;39(4):483–8.CrossRefPubMed
38.
Williams MM, Meisel MM, Williams J, Morris JC. An interdisciplinary outreach model of African American recruitment for Alzheimer's disease research. The Gerontologist. 2011;51(suppl 1):S134–41.CrossRefPubMedPubMedCentral
39.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81.CrossRefPubMed
40.
Gitlin LN, Corcoran M, Winter L, Boyce A, Hauck WW. A randomized, controlled trial of a home environmental intervention effect on efficacy and upset in caregivers and on daily function of persons with dementia. The Gerontologist. 2001;41(1):4–14.CrossRefPubMed
41.
Clemson L, Roland M, Cumming RG. Types of hazards in the homes of elderly people. Occup Ther J Res. 1997;17(3):200–13.
42.
Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. J Am Med Assoc. 2002;288(19):2469–75.CrossRef
43.
Miller WRR, S. Motivational interviewing: preparing people to change addictive behavior. New York: The Guildford Press; 1991.
44.
Sarah E. Lamb ECJ-SKHCB. Development of a common outcome data set for fall injury prevention trials: the prevention of falls network Europe consensus. J Am Geriatr Soc 2005;53(9):1618-1622.
45.
Kreuter MW, Oswald DL, Bull FC, Clark EM. Are tailored health education materials always more effective than non-tailored materials? Health Educ Res. 2000;15(3):305.CrossRefPubMed
46.
Stark SL, Silianoff TJ, Kim HL, Conte JW, and Morris JC. Tailored Calendar Journals to Ascertain Falls Among Older Adults. OTJR: Occupation, Participation and Health. 2015;35(1):53–9.
47.
Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S. The patient-reported outcomes measurement information system(PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010;63(11):1179–94.CrossRefPubMedPubMedCentral
48.
Fillenbaum GG, Smyer MA. The development, validity, and reliability of the OARS multidimensional functional assessment questionnaire. J Gerontol. 1981;36(4):P428–34.CrossRef
49.
Yardley L, Beyer N, Hauer K, Kempen G, Piot-Ziegler C, Todd C. Development and initial validation of the falls efficacy scale International (FES-I). Age Ageing. 2005;34:614–9.CrossRefPubMed
50.
Ware Jr JE, Sherbourne CD. The MOS 36-ltem short-form health Survey (SF-36): I. Conceptual framework and item selection. Med Care. 1992;30(6):473–83.CrossRefPubMed
51.
Rubenstein L, Josephson K. Falls and their prevention in elderly people: what does the evidence show? Med Clin North Am. 2006;90(5):807–24.CrossRefPubMed
52.
Blow FC. Michigan Alcoholism Screening Test-Geriatric Version (MAST-G). 1991.
53.
Yesavage JA, Sheikh JI. Geriatric depression scale (GDS) recent evidence and development of a shorter Version. Clin Gerontol. 1986;5(1–2):165–73.CrossRef
54.
Thal LJ, Grundman M, Golden R. A correlational analysis of the Blessed information-memory-concentration test and the mini-mental state exam. Neurology. 1986;36:262–4.CrossRefPubMed
55.
Tinetti ME. Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr Soc. 1986;34(2):119–26.CrossRefPubMed
56.
Radomski MV, Trombly Latham C (eds.). Occupational Therapy for Physical Dysfunction, Sixth edn: Lippincott, Willams and Wilkins; 2008.
57.
Pelli DG, Robson JG, Wilkins AJ. The design of a new letter chart for measuring contrast sensitivity. Clin Vision Sci. 1988;2(3):187–99.
58.
Clemson L, Cumming RG, Heard R. The development of an assessment to evaluate behavioral factors associated with falling. Am J Occup Ther. 2003;57(4):380–8.CrossRefPubMed
59.
Weersing VR, Rozenman M, Gonzalez A. Core components of therapy in youth: do we know what to disseminate? Behav Modif. 2009;33(1):24–47.CrossRefPubMed
60.
Cumming RG, Thomas M, Szonyi G, Frampton G, Salkeld G, Clemson L. Adherence to occupational therapist recommendations for home modifications for fall prevention. Am J Occup Ther. 2001;55(6):641–8.CrossRefPubMed
61.
Lorig K SA, Ritter P, Gonzalez V, Laurent D, & Lynch J. Outcome measures for health education and other health care interventions. Thousand Oaks, CA: Sage Publications; 1996.
62.
Cumming RG. Intervention strategies and risk-factor modification for falls prevention: a review of recent intervention studies. Clin Geriatr Med. 2002;18(2):175–89.CrossRefPubMed
63.
Campbell AJ, Robertson MC, Gardner MM, Norton RN, Buchner DM. Falls prevention over 2 years: a randomized controlled trial in women 80 years and older. Age Ageing. 1999;28(6):513–8.CrossRefPubMed
Metadata
Title
Protocol for the home hazards removal program (HARP) study: a pragmatic, randomized clinical trial and implementation study
Authors
Susan Stark
Emily Somerville
Marian Keglovits
Jane Conte
Melody Li
Yi-Ling Hu
Yan Yan
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Geriatrics / Issue 1/2017
Electronic ISSN: 1471-2318
DOI
https://doi.org/10.1186/s12877-017-0478-4

Other articles of this Issue 1/2017

BMC Geriatrics 1/2017 Go to the issue

Research article

Association between life-course socioeconomic position and inflammatory biomarkers in older age: a nationally representative cohort study in Taiwan

Research Article

Crucial aspects promoting meaning and purpose in life: perceptions of nursing home residents

Research Article

Systematic pain assessment in nursing homes: a cluster-randomized trial using mixed-methods approach

Research Article

Associations between cerebral amyloid and changes in cognitive function and falls risk in subcortical ischemic vascular cognitive impairment

Research Article

Quality of care and quality of life of people with dementia living at green care farms: a cross-sectional study

Research Article

A protective personal factor against disability and dependence in the elderly: an ordinal regression analysis with nine geographically-defined samples from Spain
Obesity Clinical Trial Summary

At a glance: The STEP trials

Read more

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Highlights from the ACC 2024 Congress

Year in Review: Pediatric cardiology

Pediatric Cardiology Video

Watch Dr. Anne Marie Valente present the last year's highlights in pediatric and congenital heart disease in the official ACC.24 Year in Review session.

Year in Review: Pulmonary vascular disease

Cardiopulmonary Comorbidity Video

The last year's highlights in pulmonary vascular disease are presented by Dr. Jane Leopold in this official video from ACC.24.

Year in Review: Valvular heart disease

Valvular Heart Disease Video

Watch Prof. William Zoghbi present the last year's highlights in valvular heart disease from the official ACC.24 Year in Review session.

Year in Review: Heart failure and cardiomyopathies

Heart Failure Video

Watch this official video from ACC.24. Dr. Biykem Bozkurt discuss last year's major advances in heart failure and cardiomyopathies.

ACC 2024 Congress Coverage

Heart Failure Video

Year in Review: Heart failure and cardiomyopathies

Watch now

Watch this official video from ACC.24. Dr. Biykem Bozkurt discuss last year's major advances in heart failure and cardiomyopathies.

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

16-04-2024 Type 2 Diabetes News

Incentivised to exercise

11-04-2024 Lifestyle Modifications News

New intervention for STEMI-related cardiogenic shock

10-04-2024 Myocardial Infarction News

» View more highlights on the ACC 2024 congress hub page

Image Credits