Effectiveness and cost-effectiveness of a telehealth intervention to support the management of long-term conditions: Study protocol for two linked randomized controlled trials

Trials

Volumn 15, Issue 1, 2014, Pages

  Thomas, Clare L ^a   Man, Mei See ^a   O'Cathain, Alicia ^b   Hollinghurst, Sandra ^a   Large, Shirley ^c   Edwards, Louisa ^a   Nicholl, Jon ^b   Montgomery, Alan A ^a,d   Salisbury, Chris ^a  

^a UNIVERSITY OF BRISTOL   (United Kingdom)

^b UNIVERSITY OF SHEFFIELD   (United Kingdom)

^c NHS Direct   (United Kingdom)

^d UNIVERSITY OF NOTTINGHAM   (United Kingdom)

Author keywords

Cardiovascular disease risk; Depression; Randomized controlled trial; Telehealth

Indexed keywords

ARTICLE; CARDIOVASCULAR DISEASE; CLINICAL PROTOCOL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COST BENEFIT ANALYSIS; COUNSELING; DEPRESSION; ECONOMICS; HEALTH CARE COST; HUMAN; INTERNET; LONG TERM CARE; MEDICAL INFORMATION SYSTEM; METHODOLOGY; MULTICENTER STUDY; PATIENT SATISFACTION; PSYCHOLOGICAL ASPECT; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; RISK REDUCTION; TELEMEDICINE; TELEPHONE; TIME; TREATMENT OUTCOME; UNITED KINGDOM;

CARDIOVASCULAR DISEASES; CLINICAL PROTOCOLS; COST-BENEFIT ANALYSIS; COUNSELING; DEPRESSION; ENGLAND; HEALTH CARE COSTS; HEALTH INFORMATION SYSTEMS; HUMANS; INTERNET; LONG-TERM CARE; PATIENT SATISFACTION; RESEARCH DESIGN; RISK FACTORS; RISK REDUCTION BEHAVIOR; TELEMEDICINE; TELEPHONE; TIME FACTORS; TREATMENT OUTCOME;

EID: 84892753531     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-15-36     Document Type: Article

References (57)

1. Department of Health Raising the Profile of Long Term Conditions Care: a compendium of information London: Her Majesty's Stationery Office (HMSO), January 2008. Available at http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_082067.pdf (accessed 10 January 2014), Department of Health.
2. Department of Health Long term conditions model. [http://webarchive.nationalarchives.gov.uk/+/www.dh.gov.uk/en/Healthcare/Longtermconditions/Longtermconditionsmodel/index.htm], Department of Health.
3. Murray E. Providing information for patients [Editorial]. BMJ 2008, 337:a280. 10.1136/bmj.a280, 18632671.
4. Steventon A, Bardsley M, Billings J, Dixon J, Doll H, Hirani S, Cartwright M, Rixon L, Knapp M, Henderson C, Rogers A, Fitzpatrick R, Hendy J, Newman S. Whole System Demonstrator Evaluation Team Effect of telehealth on use of secondary care and mortality: findings from the whole system demonstrator cluster randomised trial. BMJ 2012, 344:e3874. 10.1136/bmj.e3874, 3381047, 22723612, Whole System Demonstrator Evaluation Team.
5. García-Lizana F, Sarría-Santamera A. New technologies for chronic disease management and control: a systematic review. J Telemed Telecare 2007, 13:62-68.
6. Paré G, Jaana M, Sicotte C. Systematic review of home telemonitoring for chronic diseases: the evidence base. J Am Med Inform Assoc 2007, 14:269-277. 10.1197/jamia.M2270, 2244878, 17329725.
7. Clark RA, Inglis SC, McAlister FA, Cleland JGF, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ 2007, 334:942. 10.1136/bmj.39156.536968.55, 1865411, 17426062.
8. Murray E, Burns J, See Tai S, Lai R, Nazareth I. Interactive health communication applications for people with chronic disease. Cochrane Database Syst Rev 2005, 4:CD004274.
9. Wootton R. Twenty years of telemedicine in chronic disease management-an evidence synthesis. J Telemed Telecare 2012, 18:211-220. 10.1258/jtt.2012.120219, 3366107, 22674020.
10. Barlow J, Singh D, Bayer S, Curry R. A systematic review of the benefits of home telecare for frail elderly people and those with long-term conditions. J Telemed Telecare 2007, 13:172-179. 10.1258/135763307780908058, 17565772.
11. Cuijpers P, van Straten A, Andersson G. Internet-administered cognitive behavior therapy for health problems: a systematic review. J Behav Med 2008, 31:169-177. 10.1007/s10865-007-9144-1, 2346512, 18165893.
12. DelliFraine JL, Dansky KH. Home-based telehealth: a review and meta-analysis. J Telemed Telecare 2008, 14:62-66. 10.1258/jtt.2007.070709, 18348749.
13. Deshpande A, Khoja S, McKibbon A, Jadad AR. Real-Time (Synchronous) Telehealth in Primary Care: Systematic Review of Systematic Reviews (Technology Report 100) Ottawa: Canadian Agency for Drugs and Technologies in Health, January 2008. Available at http://www.cadth.ca/media/pdf/427A_Real-Time-Synchronous-Telehealth-Primary-Care_tr_e.pdf (accessed 12 January 2014).
14. Gaikwad R, Warren J. The role of home-based information and communications technology interventions in chronic disease management: a systematic literature review. Health Informatics J 2009, 15:122-146. 10.1177/1460458209102973, 19474225.
15. Jaana M, Paré G, Sicotte C. Home telemonitoring for respiratory conditions: a systematic review. Am J Manag Care 2009, 15:313-320.
16. Polisena J, Coyle D, Coyle K, McGill S. Home telehealth for chronic disease management: a systematic review and an analysis of economic evaluations. Int J Technol Assess Health Care 2009, 25:339-349. 10.1017/S0266462309990201, 19619353.
17. Rosser BA, Vowles KE, Keogh E, Eccleston C, Mountain GA. Technologically-assisted behaviour change: a systematic review of studies of novel technologies for the management of chronic illness. J Telemed Telecare 2009, 15:327-338. 10.1258/jtt.2009.090116, 19815901.
18. Wantland DJ, Portillo CJ, Holzemer WL, Slaughter R, McGhee EM. The effectiveness of Web-based vs. non-Web-based interventions: a meta-analysis of behavioral change outcomes. J Med Internet Res 2004, 6:e40. 10.2196/jmir.6.4.e40, 1550624, 15631964.
19. Hippisley-Cox J, Coupland C, Vinogradova Y, Robson J, Minhas R, Sheikh A, Brindle P. Predicting cardiovascular risk in England and Wales: prospective derivation and validation of QRISK2. BMJ 2008, 336:1475-1482. 10.1136/bmj.39609.449676.25, 2440904, 18573856.
20. Lewis G, Pelosi AJ, Araya R, Dunn G. Measuring psychiatric disorder in the community: a standardized assessment for use by lay interviewers. Psychol Med 1992, 22:465-486. 10.1017/S0033291700030415, 1615114.
21. Kroenke K, Spitzer RL, Williams JBW. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 2001, 16:606-613. 10.1046/j.1525-1497.2001.016009606.x, 1495268, 11556941.
22. Evans M, Kessler D, Lewis G, Peters TJ, Sharp D. Assessing mental health in primary care research using standardized scales: can it be carried out over the telephone?. Psychol Med 2004, 34:157-162. 10.1017/S0033291703008055, 14971636.
23. University of Manchester Systematic Techniques for Assisting Recruitment to Trials (MRC START). [http://www.medicine.manchester.ac.uk/mrcstart/], University of Manchester.
24. Knapp P, Raynor DK, Silcock J, Parkinson B. Can user testing of a clinical trial patient information sheet make it fit-for-purpose? A randomized controlled trial. BMC Med 2011, 9:89. 10.1186/1741-7015-9-89, 3152894, 21777435.
25. Segar J, Rogers A, Salisbury C, Thomas C. Roles and identities in transition: boundaries of work and inter-professional relationships at the interface between telehealth and primary care. Health Soc Care Community 2013, 21:606-613.
26. Improving Chronic Illness Care, MacColl Center for Health Care Innovation, Global Health Research Institute The Chronic Care Model. [http://www.improvingchroniccare.org/index.php?p=The_Chronic_Care_Model&s=2], Improving Chronic Illness Care, MacColl Center for Health Care Innovation, Global Health Research Institute.
27. NHS Choices. [http://www.nhs.uk/Pages/HomePage.aspx].
28. Bosworth HB, Olsen MK, McCant F, Harrelson M, Gentry P, Rose C, Goldstein MK, Hoffman BB, Powers B, Oddone EZ. Hypertension Intervention Nurse Telemedicine Study (HINTS): testing a multifactorial tailored behavioral/educational and a medication management intervention for blood pressure control. Am Heart J 2007, 153:918-924. 10.1016/j.ahj.2007.03.004, 17540191.
29. Bosworth HB, Powers BJ, Olsen MK, McCant F, Grubber J, Smith V, Gentry PW, Rose C, Van Houtven C, Wang V, Goldstein MK, Oddone EZ. Home blood pressure management and improved blood pressure control: results from a randomized controlled trial. Arch Intern Med 2011, 171:1173-1180. 10.1001/archinternmed.2011.276, 21747013.
30. O'Brien E, Atkins N, Stergiou G, Karpettas N, Parati G, Asmar R, Imai Y, Wang J, Mengden T, Shennan A. Working Group on Blood Pressure Monitoring of the European Society of Hypertension European Society of Hypertension International Protocol revision 2010 for the validation of blood pressure measuring devices in adults. Blood Press Monit 2010, 15:23-38. A published erratum appears in Blood Press Monit 2010, 15:171-172, 10.1097/MBP.0b013e3283360e98, 20110786, Working Group on Blood Pressure Monitoring of the European Society of Hypertension.
31. National Institute for Health and Clinical Excellence Hypertension: Clinical Management of Primary Hypertension in Adults London: NICE, National Institute for Health and Care Excellence (NICE) Clinical Guideline CG127, August 2011. Available at http://www.nice.org.uk/nicemedia/live/13561/56008/56008.pdf (accessed 12 January 2014), National Institute for Health and Clinical Excellence.
32. Pittaway S, Cupitt C, Palmer D, Arowobusoye N, Milne R, Holttum S, Pezet R, Patrick H. Comparative, clinical feasibility study of three tools for delivery of cognitive behavioural therapy for mild to moderate depression and anxiety provided on a self-help basis. Ment Health Fam Med 2009, 6:145-154. 2838647, 22477905.
33. Williams C, Wilson P, Morrison J, McMahon A, Andrew W, Allan L, McConnachie A, McNeill Y, Tansey L. Guided self-help cognitive behavioural therapy for depression in primary care: a randomised controlled trial. PLoS One 2013, 8:e52735. 10.1371/journal.pone.0052735, 3543408, 23326352.
34. Williams C. Overcoming Depression and Low Mood: a five areas approach 2009, London: Hodder Arnold, 3.
35. Big White Wall. [http://www.bigwhitewall.com/my-account/login.aspx?ReturnUrl=%2f].
36. McMillan D, Gilbody S, Richards D. Defining successful treatment outcome in depression using the PHQ-9: a comparison of methods. J Affect Disord 2010, 127:122-129. 10.1016/j.jad.2010.04.030, 20569992.
37. EuroQol Group EQ-5D-5L Value Sets. [http://www.euroqol.org/about-eq-5d/valuation-of-eq-5d/eq-5d-5l-value-sets.html], EuroQol Group.
38. Ryan RM, Plant RW, O'Malley S. Internal motivations for alcohol treatment: relations with patient characteristics, treatment involvement, and dropout. Addictive Behaviors 1995, 20:279-97. 10.1016/0306-4603(94)00072-7, 7653312.
39. Osborne RH, Elsworth GR, Whitfield K. The Health Education Impact Questionnaire (heiQ): an outcomes and evaluation measure for patient education and self-management interventions for people with chronic conditions. Patient Educ Couns 2007, 66:192-201. 10.1016/j.pec.2006.12.002, 17320338.
40. Paxton AE, Strycker LA, Toobert DJ, Ammerman AS, Glasgow RE. Starting the conversation performance of a brief dietary assessment and intervention tool for health professionals. Am J Prev Med 2011, 40:67-71. 10.1016/j.amepre.2010.10.009, 21146770.
41. Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care 1986, 24:67-74. 10.1097/00005650-198601000-00007, 3945130.
42. Norman CD, Skinner HA. eHEALS: The eHealth Literacy Scale. J Med Internet Res 2006, 8(4):e27. 10.2196/jmir.8.4.e27, 1794004, 17213046.
43. Haggerty JL, Roberge D, Freeman GK, Beaulieu C, Breton M. Validation of a generic measure of continuity of care: when patients encounter several clinicians. Ann Fam Med 2012, 10:443-51. 10.1370/afm.1378, 3438212, 22966108.
44. Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med 2006, 166:1092-7. 10.1001/archinte.166.10.1092, 16717171.
45. Montgomery AA, Fahey T, Peters TJ, MacIntosh C, Sharp DJ. Evaluation of computer based clinical decision support system and risk chart for management of hypertension in primary care: randomised controlled trial. BMJ 2000, 320:686-690. 10.1136/bmj.320.7236.686, 27312, 10710578.
46. Richards DA, Lovell K, Gilbody S, Gask L, Torgerson D, Barkham M, Bland M, Bower P, Lankshear AJ, Simpson A, Fletcher J, Escott D, Hennessy S, Richardson R. Collaborative care for depression in UK primary care: a randomized controlled trial. Psychol Med 2008, 38:279-287.
47. British Medical Association; Royal Pharmaceutical Society British National Formulary. [http://www.bnf.org/bnf/], British Medical Association; Royal Pharmaceutical Society.
48. Curtis L. Unit Costs of Health & Social Care 2012. 20th edition 2012, Canterbury, UK: University of Kent Personal Social Services Research Unit (PSSRU), Available at http://kar.kent.ac.uk/32408/1/full-with-covers.pdf (accessed 11 January 2014).
49. Department of Health Payment by Results Team Step-by-Step Guide: Calculating the 2012-13 National Tariff. [https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/216216/dh_133113.pdf], Department of Health Payment by Results Team.
50. Office for National Statistics Statistical Bulletin: Annual Survey of Hours and Earnings, 2013 Provisional Results. [http://www.ons.gov.uk/ons/dcp171778_335027.pdf], Office for National Statistics.
51. Department of Health, Medical/Vascular Policy Team Economic Modelling for Vascular Checks London: Her Majesty's Stationery Office (HMSO), 1 July 2008. Available at http://www.healthcheck.nhs.uk/document.php?o=225, Department of Health, Medical/Vascular Policy Team.
52. National Institute for Health and Clinical Excellence Guide to the Methods of Technology Appraisal London: National Institute for Health and Clinical Excellence, June 2008. Available at http://www.nice.org.uk/media/b52/a7/tamethodsguideupdatedjune2008.pdf (accessed 12 January 2014), National Institute for Health and Clinical Excellence.
53. National Collaborating Centre for Primary Care; National Institute for Health and Clinical Excellence Lipid Modification: Cardiovascular Risk Assessment and the Modification of Blood Lipids for the Primary and Secondary Prevention of Cardiovascular Disease London: National Institute for Health and Clinical Excellence, NICE Clinical Guideline CG67, March 2010. Available at http://www.nice.org.uk/nicemedia/pdf/CG67NICEguideline.pdf (accessed 12 January 2014), National Collaborating Centre for Primary Care; National Institute for Health and Clinical Excellence.
54. O'Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Hewison J. What can qualitative research do for randomised controlled trials? A systematic mapping review. BMJ Open 2013, 3:e002889. doi:10.1136/bmjopen-2013-002889, 3669723, 23794542.
55. Høifødt RS, Strøm C, Kolstrup N, Eisemann M, Waterloo K. Effectiveness of cognitive behavioural therapy in primary health care: a review. Fam Pract 2011, 28:489-504. 10.1093/fampra/cmr017, 21555339.
56. McKinstry B, Hanley J, Wild S, Pagliari C, Paterson M, Lewis S, Sheikh A, Krishan A, Stoddart A, Padfield P. Telemonitoring based service redesign for the management of uncontrolled hypertension: multicentre randomised controlled trial. BMJ 2013, 346:f3030. 10.1136/bmj.f3030, 3663293, 23709583.
57. McManus RJ, Mant J, Bray EP, Holder R, Jones MI, Greenfield S, Kaambwa B, Banting M, Bryan S, Little P, Williams B, Hobbs FD. Telemonitoring and self-management in the control of hypertension (TASMINH2): a randomised controlled trial. Lancet 2010, 376:163-172. 10.1016/S0140-6736(10)60964-6, 20619448.