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Open Access 01-12-2017 | Study protocol

Effectiveness of sensor monitoring in an occupational therapy rehabilitation program for older individuals after hip fracture, the SO-HIP trial: study protocol of a three-arm stepped wedge cluster randomized trial

Authors: Margriet C. Pol, Gerben ter Riet, Margo van Hartingsveldt, Ben Kröse, Sophia E. de Rooij, Bianca M. Buurman

Published in: BMC Health Services Research | Issue 1/2017

Abstract

Background

The performance of activities of daily living (ADL) at home is important for the recovery of older individuals after hip fracture. However, 20–90% of these individuals lose ADL function and never fully recover. It is currently unknown to what extent occupational therapy (OT) with coaching based on cognitive behavioral treatment (CBT) improves recovery. The same holds for sensor monitoring-based coaching in addition to OT. Here, we describe the design of a study investigating the effect of sensor monitoring embedded in an OT rehabilitation program on the recovery of ADL among older individuals after hip fracture.

Methods/ Design

Six nursing homes will be randomized in a three-arm stepped wedge cluster randomized trial. All nursing homes will initially provide standard care. At designated time points, nursing homes, successively and in random order, will cross over to the provision of OT and at the next time point, to sensor monitoring-enhanced OT. A total of 288 older individuals, previously living alone in the community, who after a hip fracture were admitted to a geriatric rehabilitation ward for a short-term rehabilitation, will be enrolled.

Individuals in the first intervention group (OTc) will participate in an OT rehabilitation program with coaching based on cognitive behavioral therapy (CBT) principles. In the sensor monitoring group, sensor monitoring is added to the OT intervention (OTcsm). Participants will receive a sensor monitoring system consisting of (i) an activity monitor during nursing home stay, (ii) a sensor monitoring system at home and a (iii) a web-based feedback application. These components will be embedded in the OT. The OT consists of a weekly session with an occupational therapist during the nursing home stay followed by four home visits and four telephone consultations. The primary outcome is patient-perceived daily functioning at 6 months, assessed using the Canadian Occupational Performance Measure (COPM).

Discussion

As far as we know, this study is the first large-scale stepped wedge trial, studying the effect of sensor monitoring embedded in an OT coaching program. The study will provide new knowledge on the combined intervention of sensor monitoring and coaching in OT as a part of a rehabilitation program to enable older individuals to perform everyday activities and to remain living independently after hip fracture.

Trial registration number

Netherlands National Trial Register, NTR 5716

Date registered: April 1 2016

Folbert E, Smit R, Velde D. Multidisciplinair zorgpad voor oudere patiënten met een heupfractuur: resultaten van implementatie in het Centrum voor Geriatrische Traumatologie, Almelo. Ned Tijdschr Geneeskd. 2011;155:A3197.PubMed

Magaziner J, Hawkes W, Hebel JR, Zimmerman SI, Fox KM, Dolan M, et al. Recovery from hip fracture in eight areas of function. J Gerontol A Biol Sci Med Sci. 2000;55(9):M498–507. doi:10.1093/gerona/55.9.M498.CrossRefPubMed

Crotty M, Unroe K, Cameron ID, Miller M, Ramirez G, Couzner L. Rehabilitation interventions for improving physical and psychosocial functioning after hip fracture in older people. Cochrane Database Syst Rev. 2010;1. doi:10.1002/14651858.cd007624.pub3

Mossey JM, Mutran E, Knott K, Craik R. Determinants of recovery 12 months after hip fracture: the importance of psychosocial factors. Am J Public Health. 1989;79(3):279–86. doi:10.2105/AJPH.79.3.279.CrossRefPubMedPubMedCentral

Givens JL, Sanft TB, Marcantonio ER. Functional recovery after hip fracture: the combined effects of depressive symptoms, cognitive impairment, and delirium. J Am Geriatr Soc. 2008;56(6):1075–9. doi:10.1111/j.1532-5415.2008.01711.x.CrossRefPubMed

Osnes E, Lofthus C, Meyer H, Falch J, Nordsletten L, Cappelen I, et al. Consequences of hip fracture on activities of daily life and residential needs. Osteoporosis Int. 2004;15(7):567–74. doi:10.1007/s00198-003-1583-0.CrossRef

Visschedijk J, Achterberg W, Van Balen R, Hertogh C. Fear of falling after hip fracture: a systematic review of measurement instruments, prevalence, interventions, and related factors. J Am Geriatr Soc. 2010;58(9):1739–48. doi:10.1111/j.1532-5415.2010.03036.x.CrossRefPubMed

Scheffer AC, Schuurmans MJ, van Dijk N, van der Hooft T, de Rooij SE. Fear of falling: measurement strategy, prevalence, risk factors and consequences among older persons. Age Ageing. 2008;37(1):19–24. doi:10.1093/ageing/afm169.CrossRefPubMed

Resnick B, Hicks G, Orwig D, Yu-Yahiro J, Magaziner J. Review of the impact of exercise interventions on function post hip fracture and recommendations for future interventions. Int J Disability Community Rehabil. 2010;9(1). http://www.ijdcr.ca/VOL09_01/articles/resnick.shtml.

10.

Handoll HH, Sherrington C, Mak J. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Library. 2011. doi:10.1002/14651858.cd001704.pub4doi:10.1590/s1516-31802011000600012.

11.

Auais MA, Eilayyan O, Mayo NE. Extended exercise rehabilitation after hip fracture improves patients’ physical function: a systematic review and meta-analysis. Phys Ther. 2012;92(11):1437–51. doi:10.2522/ptj.20110274.CrossRefPubMed

12.

Latham NK, Harris BA, Bean JF, Heeren T, Goodyear C, Zawacki S, et al. Effect of a Home-Based Exercise Program on Functional Recovery Following Rehabilitation After Hip Fracture: A Randomized Clinical Trial. JAMA. 2014;311(7):700–8. doi:10.1001/jama.2014.469.CrossRefPubMedPubMedCentral

13.

Zijlstra G, Van Haastregt J, Ambergen T, Van Rossum E, Van Eijk, Jacques Th M, Tennstedt SL, et al. Effects of a Multicomponent Cognitive Behavioral Group Intervention on Fear of Falling and Activity Avoidance in Community-Dwelling Older Adults: Results of a Randomized Controlled Trial. J Am Geriatr Soc. 2009;57(11):2020-8. doi:10.1111/j.1532-5415.2009.02489.x

14.

Murphy SL, Williams CS, Gill TM. Characteristics Associated with Fear of Falling and Activity Restriction in Community‐Living Older Persons. J Am Geriatr Soc. 2002;50(3):516–20. doi:10.1046/j.1532-5415.2002.50119.x.CrossRefPubMedPubMedCentral

15.

Volpato S, Guralnik JM. Hip fractures: comprehensive geriatric care and recovery. Lancet. 2015. doi:10.1016/S0140-6736(14)61592-0.

16.

Dorresteijn TA, Zijlstra GA, Delbaere K, van Rossum E, Vlaeyen JW, Kempen GI. Evaluating an in-home multicomponent cognitive behavioural programme to manage concerns about falls and associated activity avoidance in frail community-dwelling older people: Design of a randomised control trial [NCT01358032. BMC Health Serv Res. 2011 Sep 20;11:228,6963-11-228.

17.

Di Monaco M, Vallero F, De Toma E, De Lauso L, Tappero R, Cavanna A. A single home visit by an occupational therapist reduces the risk of falling after hip fracture in elderly women: a quasi-randomized controlled trial. J Rehabil Med. 2008;40(6):446–50. doi:10.2340/16501977-0206.CrossRefPubMed

18.

Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, et al. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012;9(11). doi:10.1002/14651858.CD007146.pub3

19.

Pol MC, Poerbodipoero S, Robben S, Daams J, van Hartingsveldt M, de Vos R, et al. Sensor Monitoring to Measure and Support Daily Functioning for Independently Living Older People: A Systematic Review and Road Map for Further Development. J Am Geriatr Soc. 2013;61(12):2219–27. doi:10.1111/jgs.12563.CrossRefPubMed

20.

McDermott MS, While AE. Maximizing the healthcare environment: a systematic review exploring the potential of computer technology to promote self-management of chronic illness in healthcare settings. Patient Educ Couns. 2013;92(1):13–22. doi:10.1016/j.pec.2013.02.014.CrossRefPubMed

21.

van der Weegen S, Verwey R, Spreeuwenberg M, Tange H, van der Weijden T, de Witte L. The development of a mobile monitoring and feedback tool to stimulate physical activity of people with a chronic disease in primary care: a user-centered design. JMIR mhealth uhealth. 2013;1(2):e8. doi:10.2196/mhealth.2526.CrossRefPubMedPubMedCentral

22.

van Hoof J, Kort HS, Rutten PG, Duijnstee MS. Ageing-in-place with the use of ambient intelligence technology: perspectives of older users. Int J Med Inform. 2011;80(5):310–31. doi:10.1016/j.ijmedinf.2011.02.010.CrossRefPubMed

23.

Pol M, van Nes F, van Hartingsveldt M, Buurman B, de Rooij S, Krose B. Older People’s Perspectives Regarding the Use of Sensor Monitoring in Their Home. Gerontologist. 2014. doi:10.1093/geront/gnu104.PubMed

24.

Kanis M, Robben S, Hagen J, Bimmerman A, Wagelaar N, Kröse B. Sensor monitoring in the home: giving voice to elderly people. Proceedings of the 7th International Conference on Pervasive Computing Technologies for Healthcare; ICST (Institute for Computer Sciences, Social-Informatics and Telecommunications Engineering); 2013. doi:10.4108/icst.pervasivehealth.2013.252060

25.

Auais M, Morin S, Nadeau L, Finch L, Mayo N. Changes in frailty-related characteristics of the hip fracture population and their implications for healthcare services: evidence from Quebec, Canada. Osteoporosis Int. 2013;24(10):2713–24. doi:10.1007/s00198-013-2390-x.CrossRef

26.

World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subject. 64th WMA General Assembly in Fortaleza, Brazil: World Medical Association..2013.

27.

Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux P, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010;63(8):e1–e37. doi:10.1016/j.jclinepi.2010.03.004.CrossRefPubMed

28.

Steultjens E, Robertson K. Focussed, comprehensive home visits prevent falling when targeted to specific groups of older people at high risk of falls. Aust Occup Ther J. 2009;56(2):144–5. doi:10.1111/j.1440-1630.2009.788_1.x.CrossRefPubMed

29.

Steultjens EM, Dekker J, Bouter LM, Leemrijse CJ, van den Ende CH. Evidence of the efficacy of occupational therapy in different conditions: an overview of systematic reviews. Clin Rehabil. 2005;19(3):247–54. doi:10.1191/0269215505cr870oa.CrossRefPubMed

30.

Hagsten B, Svensson O, Gardulf A. Early individualized postoperative occupational therapy training in 100 patients improves ADL after hip fracture A randomized trial. Acta Orthop. 2004;75(2):177–83. doi:10.1080/00016470412331294435.CrossRef

31.

Townsend EA, Polatajko HJ. Advancing an occupational therapy vision for health, well-being, and justice through occupation. Ottawa, ON: CAOT Publications ACE.«Enabling Occupation II présente une vue en coupe tranversale du MCRO-P pour définir et délimiter le domaine de préoccupation des ergothérapeutes, c’est-àdire l’occupation humaine. 2007.

32.

Kasteren TLMv. Activity recognition for health monitoring elderly using temporal probabilistic models. Amsterdam: ASCI; 2011.

33.

Robben S, Pol M, Kröse B. Longitudinal ambient sensor monitoring for functional health assessments: a case study. Proceedings of the 2014 ACM International Joint Conference on Pervasive and Ubiquitous Computing: Adjunct Publication; ACM; 2014. doi:10.1145/2638728.2638812

34.

Vooijs M, Alpay LL, Snoeck-Stroband JB, Beerthuizen T, Siemonsma PC, Abbink JJ, et al. Validity and usability of low-cost accelerometers for internet-based self-monitoring of physical activity in patients with chronic obstructive pulmonary disease. Interact J Med Res. 2014;3(4):e14. doi:10.2196/ijmr.3056.CrossRefPubMedPubMedCentral

35.

Law M, Baptiste S, McColl M, Opzoomer A, Polatajko H, Pollock N. The Canadian occupational performance measure: an outcome measure for occupational therapy. Can J Occup Ther. 1990;57(2):82–7. doi:10.1177/000841749005700207.CrossRefPubMed

36.

Cup EH, Scholte op Reimer WJ, Thijssen MC, van Kuyk-Minis MA. Reliability and validity of the Canadian Occupational Performance Measure in stroke patients. Clin Rehabil. 2003;17(4):402-9. doi:10.1191/0269215503cr635oal;17(4):402-9.

37.

Dedding C, Cardol M, Eyssen IC, Dekker J, Beelen A. Validity of the Canadian Occupational Performance Measure: a client-centred outcome measurement. Clin Rehabil. 2004;18(6):660–7. doi:10.1191/0269215504cr746oa.CrossRefPubMed

38.

Eyssen IC, Beelen A, Dedding C, Cardol M, Dekker J. The reproducibility of the Canadian Occupational Performance Measure. Clin Rehabil. 2005;19(8):888–94. doi:10.1191/0269215505cr883oa.CrossRefPubMed

39.

Sturkenboom IH, Graff MJ, Hendriks JC, Veenhuizen Y, Munneke M, Bloem BR, et al. Efficacy of occupational therapy for patients with Parkinson’s disease: a randomised controlled trial. Lancet Neurol. 2014;13(6):557–66. doi:10.1016/S1474-4422(14)70055-9.CrossRefPubMed

40.

Eyssen I, Steultjens M, Oud T, Bolt EM, Maasdam A, Dekker J. Responsiveness of the Canadian occupational performance measure. J Rehabil Res Dev. 2011;48(5):517–28. doi:10.1682/JRRD.2010.06.0110.CrossRefPubMed

41.

Tinetti ME. Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr Soc. 1986. doi:10.1111/j.1532-5415.1986.tb05480.x.PubMed

42.

Faber MJ, Bosscher RJ, van Wieringen PC. Clinimetric properties of the performance-oriented mobility assessment. Phys Ther. 2006;86(7):944–54.PubMed

43.

Podsiadlo D, Richardson S. The timed “Up & Go”: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39(2):142–8. doi:10.1111/j.1532-5415.1991.tb01616.x.CrossRefPubMed

44.

Helbostad JL, Sletvold O, Moe-Nilssen R. Effects of home exercises and group training on functional abilities in home-dwelling older persons with mobility and balance problems. A randomized study. Aging Clin Exp Res. 2004;16(2):113–21. doi:10.1007/BF03324539.CrossRefPubMed

45.

Bohannon RW. Reference values for the timed up and go test: a descriptive meta-analysis. J Geriatr Phys Ther. 2006;29(2):64–8.CrossRefPubMed

46.

Kristensen MT, Foss NB, Kehlet H. Timed “up & go” test as a predictor of falls within 6 months after hip fracture surgery. Phys Ther. 2007;87(1):24–30. doi:10.2522/ptj.20050271.CrossRefPubMed

47.

Crotty M, Whitehead C, Miller M, Gray S. Patient and caregiver outcomes 12 months after home-based therapy for hip fracture: a randomized controlled trial. Arch Phys Med Rehabil. 2003;84(8):1237–9. doi:10.1016/S0003-9993(03)00141-2.CrossRefPubMed

48.

Prestmo A, Hagen G, Sletvold O, Helbostad JL, Thingstad P, Taraldsen K, et al. Comprehensive geriatric care for patients with hip fractures: a prospective, randomised, controlled trial. Lancet. 2015. doi:10.1016/S0140-6736(14)62409-0.PubMed

49.

Katz S, Ford AB, Moskowitz RW, Jackson BA, Jaffe MW. Studies of Illness in the Aged. the Index of Adl: a Standardized Measure of Biological and Psychosocial Function. JAMA. 1963;185:914-9. doi:10.1001/jama.1963.03060120024016

50.

Weinberger M, Samsa GP, Schmader K, Greenberg SM, Carr DB, Wildman DS. Comparing proxy and patients’ perceptions of patients’ functional status: results from an outpatient geriatric clinic. J Am Geriatr Soc. 1992;40(6):585–8. doi:10.1111/j.1532-5415.1992.tb02107.x.CrossRefPubMed

51.

Scheffer AC, Schuurmans MJ, Vandijk N, Van Der Hooft T, De Rooij SE. Reliability and validity of the visual analogue scale for fear of falling in older persons. J Am Geriatr Soc. 2010;58(11):2228–30. doi:10.1111/j.1532-5415.2010.03105.x.CrossRefPubMed

52.

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(6):614–9. doi:10.1093/ageing/afi196.CrossRefPubMed

53.

Visschedijk JH, Terwee CB, Caljouw MA, Spruit-van Eijk M, van Balen R, Achterberg WP. Reliability and validity of the Falls Efficacy Scale-International after hip fracture in patients aged &geq; 65 years. Disability Rehabil. 2015(0):1-8.

54.

Group TE. EuroQol-a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199–208. doi:10.1016/0168-8510(90)90421-9.CrossRef

55.

Parsons N, Griffin XL, Achten J, Costa ML. Outcome assessment after hip fracture: is EQ-5D the answer? Bone Joint Res. 2014;3(3):69–75. doi:10.1302/2046-3758.33.2000250.CrossRefPubMedPubMedCentral

56.

Davey C, Hargreaves J, Thompson JA, Copas AJ, Beard E, Lewis JJ, et al. Analysis and reporting of stepped wedge randomised controlled trials: synthesis and critical appraisal of published studies, 2010 to 2014. Trials. 2015 Aug 17;16:358,015-0838-3.

57.

Strauss A, Corbin J. Grounded theory methodology. Handbook of qualitative research. 1994:273-85. doi:10.1016/j.jclinepi.2014.02.016

58.

Copas AJ, Lewis JJ, Thompson JA, Davey C, Baio G, Hargreaves JR. Designing a stepped wedge trial: three main designs, carry-over effects and randomisation approaches. Trials. 2015 Aug 17;16:352,015-0842-7.

59.

Keriel-Gascou M, Buchet-Poyau K, Rabilloud M, Duclos A, Colin C. A stepped wedge cluster randomized trial is preferable for assessing complex health interventions. J Clin Epidemiol. 2014;67(7):831–3. doi:10.1016/j.jclinepi.2014.02.016.CrossRefPubMed

Title: Effectiveness of sensor monitoring in an occupational therapy rehabilitation program for older individuals after hip fracture, the SO-HIP trial: study protocol of a three-arm stepped wedge cluster randomized trial
Authors: Margriet C. Pol
Gerben ter Riet
Margo van Hartingsveldt
Ben Kröse
Sophia E. de Rooij
Bianca M. Buurman
Publication date: 01-12-2017
Publisher: BioMed Central
Published in: BMC Health Services Research / Issue 1/2017
Electronic ISSN: 1472-6963
DOI: https://doi.org/10.1186/s12913-016-1934-0

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Effectiveness of sensor monitoring in an occupational therapy rehabilitation program for older individuals after hip fracture, the SO-HIP trial: study protocol of a three-arm stepped wedge cluster randomized trial

Abstract

Background

Methods/ Design

Discussion

Trial registration number

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods/ Design

Discussion

Trial registration number

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