Message-based Rehabilitation for Peripheral Artery Disease Patients Clinical Trial
Official title:
The Effectiveness of Text Message-based Rehabilitation Program on Cardiometabolic Risk Factors for Patients With Peripheral Artery Disease Post-surgical Revascularization: A Randomized Controlled Trial
Background: Many patients with peripheral artery disease are unable to achieve healthy
lifestyle after revascularization. There is evidence that rehabilitation program could result
in decreased re-admission, reduced cardiometabolic risk factors and improved quality of life.
Aim: This first randomized controlled trial to examine the effectiveness of mobile phone text
message-based rehabilitation on low density lipoprotein (LDL), Ankle Brachial Index (ABI),
healthy lifestyle behaviors and quality of life for patients after revascularization.
Methods: This is a 6 months randomized controlled trial. It is hypothesized that
message-based rehabilitation program will be effective in improving the low density
lipoprotein (LDL), Ankle Brachial Index (ABI), healthy lifestyle behaviors and quality of
life for patients with peripheral artery disease after surgical revascularization. A total of
160 participants will be recruited for the study. The participants will be randomly divided
into intervention and control groups. Both intervention and control groups will receive
face-to-face lifestyle adherence counseling and booklet at baseline. The intervention group
will receive 4 mobile phone messages per week for 24 weeks.
All participants will be asked to fill in the questionnaires at the baseline, 6-week and
6-month follow-up in Surgical Out Patient Department (SOPD). Participants' blood results of
low density lipoprotein (LDL) at the baseline and at 6-month follow-up will be retrieved from
Computer Management System in SOPD The primary outcomes are the fasting LDL levels at 6
months. Secondary outcome are Ankle-Brachial Index (ABI), BMI, Fasting glucose level, HDL
level, Total cholesterol level, self-reported adherence to healthy lifestyle behaviours,
quality of life and smoking status.
Participants: The target participants of this study are peripheral artery disease patients
who have received revascularization in the Surgical Department of a regional hospital in Hong
Kong. The eligible participants are Chinese, aged 50 years or above, and with medical record
of peripheral artery disease with revascularization done in the past 6 months. The
participants should be able to receive and read Chinese texts from their own mobile phones
and are available to come back for a 6-month follow-up for lifestyle counselling. The
potential participants will be excluded if they refuse to provide an informed-consent form or
if they have medical records stating their lack of capacity to provide informed consent. The
recruitment procedure will take place in Department of Surgery in a regional hospital.
Study setting: The study will be conducted in the Surgical Department of a regional hospital
in Hong Kong.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | June 30, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 100 Years |
Eligibility |
Inclusion Criteria: Aged above 50 Clinical diagnosis of peripheral artery disease Received revascularization in the past 6 months. Must be able to receive and read Chinese messages from their own mobile phones Must be able to come back for a 6-week and 6-month follow-up for lifestyle counselling and blood sample taking. Exclusion Criteria: Refuse to provide an informed-consent form. Clinical diagnosis of lack of capacity to provide informed consent. |
Country | Name | City | State |
---|---|---|---|
China | Choy Hau Kim | Hong Kong | |
Hong Kong | Choy Hau Kim | Hong Kong | HK |
Lead Sponsor | Collaborator |
---|---|
Caritas Institute of Higher Education |
China, Hong Kong,
Chow CK, Redfern J, Hillis GS, Thakkar J, Santo K, Hackett ML, Jan S, Graves N, de Keizer L, Barry T, Bompoint S, Stepien S, Whittaker R, Rodgers A, Thiagalingam A. Effect of Lifestyle-Focused Text Messaging on Risk Factor Modification in Patients With Co — View Citation
Cohen J. Statistical power analyses for the social sciences. Hillsdale, NJ, Lawrence Erlbauni Associates. 1988.
Dunlay SM, Witt BJ, Allison TG, Hayes SN, Weston SA, Koepsell E, Roger VL. Barriers to participation in cardiac rehabilitation. Am Heart J. 2009 Nov;158(5):852-9. doi: 10.1016/j.ahj.2009.08.010. Epub 2009 Sep 29. — View Citation
European Stroke Organisation, Tendera M, Aboyans V, Bartelink ML, Baumgartner I, Clément D, Collet JP, Cremonesi A, De Carlo M, Erbel R, Fowkes FG, Heras M, Kownator S, Minar E, Ostergren J, Poldermans D, Riambau V, Roffi M, Röther J, Sievert H, van Sambe — View Citation
Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FG, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RA, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Wals — View Citation
Goel K, Lennon RJ, Tilbury RT, Squires RW, Thomas RJ. Impact of cardiac rehabilitation on mortality and cardiovascular events after percutaneous coronary intervention in the community. Circulation. 2011 May 31;123(21):2344-52. doi: 10.1161/CIRCULATIONAHA. — View Citation
Hankey GJ, Norman PE, Eikelboom JW. Medical treatment of peripheral arterial disease. JAMA. 2006 Feb 1;295(5):547-53. Review. — View Citation
Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. — View Citation
Hong Kong Census and Statistics Department: Information Technology usage 2016. Retrieved from https://www.censtatd.gov.hk/hkstat/sub/gender/itu/index.jsp.
Khan S, Cleanthis M, Smout J, Flather M, Stansby G. Life-style modification in peripheral arterial disease. Eur J Vasc Endovasc Surg. 2005 Jan;29(1):2-9. Review. — View Citation
Pfaeffli Dale L, Whittaker R, Jiang Y, Stewart R, Rolleston A, Maddison R. Text Message and Internet Support for Coronary Heart Disease Self-Management: Results From the Text4Heart Randomized Controlled Trial. J Med Internet Res. 2015 Oct 21;17(10):e237. — View Citation
Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997 Sep-Oct;12(1):38-48. Review. — View Citation
Rantner B, Kollerits B, Pohlhammer J, Stadler M, Lamina C, Peric S, Klein-Weigel P, Mühlthaler H, Fraedrich G, Kronenberg F. The fate of patients with intermittent claudication in the 21st century revisited - results from the CAVASIC Study. Sci Rep. 2017 — View Citation
Wagner III WE. Using IBM® SPSS® statistics for research methods and social science statistics. Sage Publications; 2014 Mar 20.
Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of Fasting blood low density lipoprotein (LDL) level | Fasting blood low density lipoprotein (LDL) level | Change from the baseline and 6-month follow-up. | |
Secondary | Change of Smoking status | self-reported 7-day point prevalence abstinence and validated by exhaled carbon monoxide monitor (<4 ppm) | Change from baseline, 6- week and 6-month follow-up | |
Secondary | Change of Readiness for behavioural changes | Measured by Patient Activation Measure | Change from baseline, 6- week and 6-month follow-up | |
Secondary | Change of Health related Quality of life | Measured by SF12v2 | Change from baseline, 6- week and 6-month follow-up | |
Secondary | Change of BMI | Body Mas Index | Change from baseline, 6- week and 6-month follow-up | |
Secondary | Change of ABI | Ankle-Brachial Index | Change from baseline, 6- week and 6-month follow-up | |
Secondary | Change of Fasting glucose level | Fasting glucose level | Change from baseline and 6-month follow-up | |
Secondary | Change of HDL level | HDL level | Change from baseline and 6-month follow-up | |
Secondary | Change of Total cholesterol level | Total cholesterol level | Change from baseline and 6-month follow-up |