Effectiveness of Text Message-based Rehabilitation Program for Patients With Peripheral Artery Disease

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.

Study Overview

• Status: Unknown
• Conditions: Message-based Rehabilitation for Peripheral Artery Disease Patients
• Intervention / Treatment: Behavioral: Message-based lifestyle intervention

Detailed Description

Background Peripheral artery disease (PAD) is a circulatory disease which associated with narrowing of arteries in the lower limbs. It is also a common atherosclerotic vascular disease affecting 3-12% of the global population [1]. With aging of the global population and increasing industrialization, PAD is expected to increase further in the next few decades. Worse of all, PAD increases risk of coronary, cerebrovascular complication including death [2]. So secondary prevention is essential for patients with PAD especially after revascularization.

There is robust evidence that the secondary prevention of peripheral artery disease can be achieved by lifestyle modification [3-4]. The American Heart Association (AHA) recommended that smoking cessation, glycemic control and structured exercise are import elements of care for patient with PAD [5]. Despite the need of secondary prevention and the evidence-based guidelines from AHA, there is no structured rehabilitation program for PAD patients in Hong Kong. Recent studies reported secondary prevention of PAD mainly focus on exercise and medication therapy. However, a single lifestyle behavioral change could not address the needs of the patients who have multiple lifestyle risk factors. Since many PAD patients have more than one lifestyle risk factor, the rehabilitation program targeting multiple lifestyle behavioral changes will be more benefit to the at risk patients.

Mobile-rehabilitation is a new concept to deliver the rehabilitation program. Center-based rehabilitation is well evidenced to reduce mortality, unplanned hospital admissions and improve quality of life and psychological well-being of the patients [6]. However, its benefits is limited by low referral rate and inaccessibility of program site [7]. Mobile phone messaging can be used to motivate and reinforce the lifestyle behavioral changes. It can also prevent patients from relapsing to the previous unhealthy lifestyle behavioral stage. Current studies show a positive result of using texting to promote healthy lifestyle behaviors among adults with cardiovascular disease [8-9]. Considering that the mobile-phone penetration rate in Hong Kong is about 96.1% [10], the use of texting can be an innovative and cost-effective tool to promote a healthy lifestyle and improve quality of life of PAD patients.

To the best of the author's knowledge, there have been no Randomized Controlled Trial (RCT) of a stand-alone mobile phone message-based rehabilitation program designed to help peripheral artery disease patients. This is the first randomized controlled trial to examine the effectiveness of message-based rehabilitation on cardiometabolic risk factors for PAD patients who have received surgical revascularization. The transtheorectical model (TTM) [11] will be used as a framework for conceptualizing the process of behavior change. This model is well-suited to this messaging-based intervention as it allows understanding of participants' processes and dynamics of behavioral changes.

2. Aim This single-blinded randomized controlled trial aimed to evaluate the effectiveness of the message-based rehabilitation on fasting low density lipoprotein (LDL) level, Ankle-Brachial Index (ABI), healthy lifestyle behaviours, quality of life and smoking status for PAD patients who have received revascularization.

3. Research hypothesis The research hypothesis is that the message-based rehabilitation program improve the LDL, ABI and the cardiometabolic risk factors of peripheral artery disease (PAD) patients who have received revascularization.

4. Methodology 4.1 Study design This pilot randomised controlled trial aimed at examining the effectiveness of message-based lifestyle intervention. Peripheral artery disease patients who have received revascularization in the past 6 months, are randomized into 2 groups. The total sample size will be 160. Both intervention and control groups will receive face-to-face lifestyle adherence counseling and booklets at baseline. The intervention group will receive 4 mobile phone messages per week for 24 weeks. The messages are motivational advice to support lifestyle behavioral modification in various stages of behavioral changes. All participants will be follow up at 6-week and 6-month in Surgical Out Patient Department. Participants' ABI, lifestyle behaviors and quality of life will be assessed at baseline, 6- week and 6-month follow-up. Participants' fasting low density lipoprotein (LDL) level at baseline and at 6-month follow up will be retrieved from Computer Management System with approval of Dr. Leung Siu-kee, Chief Of Service Department of Surgery Tuen Mun Hospital. At least ten participants from intervention group will be purposively selected for individual face-to-face semi-structured interview to evaluate the mobile phone-based rehabilitation program at 6-month follow-up.

4.2 Study outcomes

Primary outcomes:

- Fasting blood low density lipoprotein (LDL) level

Secondary outcome:

• Smoking status
• Readiness for behavioural changes
• Health related Quality of life
• Self-reported walking physical exercise (session per week)
• Self-reported serving fruits and vegetables consumed per day
• BMI
• Fasting glucose level
• HDL level
• Total cholesterol level
• ABI

4.3 Study setting The study will be conducted in the Department of Surgery in Tuen Mun Hospital

4.4 Sampling method Probability sampling (simple random sampling) will be adopted for this study. Simple individual randomization method by sequentially numbered, opaque sealed envelopes (SNOSE) will be used to ensure the PI and participants will be concealed from the allocation sequence. The trained research assistant will prepare 160 identical, opaque, sealed, A5-sized envelops, with a unique 3-digit serial number on the cover of each envelope as an identifier. Half of them will each contain a card indicating "intervention" and the other half, " control". After consent, the trained research assistant will open an envelope according to the sequence of the serial number and assign participant to either "intervention" or "control" group. The envelop must be opened according to the serial number. All others will not know the group allocation before the envelope is opened. Frequent checks (at least weekly) of these numbers will be done to ensure no deviation.

4.5 Sample size Sample size will be determined according to power (1-β), type 1 error (α), and effect size. The mean effect size of lifestyle intervention from a previous study is 0.4, which is a medium effect size according to Cohen 1998 [12]. Thus, an effect size of 0.4 was used in the calculations. To achieve the conventional level of 80% power and α= 5%, the sample size will be 128. The attrition rate in previous studies ranged from 16%-20%. A total of 160 participants will ultimately be required; 80 participants will be randomized to either intervention or control group.

4.6 Study intervention The message-based lifestyle intervention consists of three parts. Both the intervention and control groups will receive Parts I and II. Only the intervention group will receive Part III, which is the mobile phone messaging.

Part I: Conduct an individualized healthy lifestyle education The first part is face-to-face individual health education with supportive brief counselling. It consists of the identification of lifestyle risk factors and modification strategies for secondary prevention of PAD. This counselling service will be provided by Site Supervisor, Mr. Ng Hoi Wa. A measurable and realistic lifestyle modification plan will be established together with the client and the site supervisor.

Part II: Develop a healthy lifestyle booklet The second part is a reinforcement tool for face-to-face education. The research team will develop a booklet includes misconceptions, maladaptive beliefs, facilitators and barriers of healthy lifestyle modification.

Part III: Perform mobile phone-based messaging The trained research assistant will deliver the messages to the participants of the intervention group for 24 weeks throughout the study. The messages will act as a reinforcement to increase self-awareness about health-promoting behaviour and develop the desire for competence in achieving a healthy lifestyle.

5. Data collection The quantitative data will be collected by using questionnaires. The trained research assistant will explain the nature and purpose of the research to the potential participants in interview room in Department of Surgery. The eligible participants are requested to sign the informed-consent forms and reminded that their participation is voluntary. The participants are also requested to fill in two questionnaires, Patient Activation Measure [13] & Short Form 12 version 2 (SF12v2) [14], at the baseline, 6-week and 6-month follow-up. The participants' blood result of fasting low density lipoprotein (LDL) level will be retrieved from computer management system in Department of Surgery. Face-to-face individual semi-structured interviews will be conducted to collect qualitative data.

6. Data analysis Quantitative data will be analysed using International Business Machines Corporation(IBM) Statistics is leading statistical software (SPSS) version 22.0 [15]. The descriptive measures of all participants will be summarised by percentage, mean, and 95% confidence interval (CI), as well as compared for between-group differences. The t-test will be conduct to compare the differences in continuous variables between the intervention and control groups.

The qualitative data will be audio-recorded and analysed by thematic analysis. Seven open-ended questions will be used in the semi-structured interviews.

1. How do you feel about the mobile phone text message-based rehabilitation?
2. What factors encouraged you to participate in Peripheral Artery Disease Rehabilitation program?
3. What factors discouraged you from participate in Peripheral Artery Disease Rehabilitation program?
4. How did the mobile phone text message-based rehabilitation facilitate your participation in lifestyle modification?
5. How easy did you find following the lifestyle advice from the mobile phone text message?
6. How difficult did you find following the lifestyle advice from mobile phone text message?
7. Any suggestions on how to improve and promote the rehabilitation for patients with peripheral artery disease?

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hau Kim CHOY, MSc; Phone Number: 4262 852 3702 4262; Email: hkchoy@cihe.edu.hk
• Study Contact Backup: Name: Hoi Wa NG, MSc; Phone Number: +852 63808505; Email: nhw716@ha.org.hk

Study Locations

• China
  • Hong Kong, China
    • Recruiting
    • Choy Hau Kim
    • Contact: Hau Kim CHOY, MSc; Phone Number: 4262 +852 3702 4262; Email: hkchoy@cihe.edu.hk
    • Contact: Hoi Wa NG, MSc; Phone Number: +852 6380 8505; Email: nhw716@ha.org.hk
    • Sub-Investigator: Po Tai CHAN, PhD
    • Sub-Investigator: Wei Han HUI, MBBS
    • Sub-Investigator: Albert Kit Yu NG, MBBS
    • Sub-Investigator: Hoi Wa NG, MSc
    • Sub-Investigator: Ha Kan CHU, MSc
    • Sub-Investigator: Lisa Pau Le LOW, PhD
    • Principal Investigator: Hau Kim CHOY, MSc
• Hong Kong
  • HK
    • Hong Kong, HK, Hong Kong, HK
      • Recruiting
      • Choy Hau Kim
      • Contact: Hau Kim CHOY, MSc; Phone Number: 4262 +852 3702 4262; Email: hkchoy@cihe.edu.hk
      • Contact: Hoi Wa NG, MSc; Phone Number: +852 6380 8505; Email: nhw716@ha.org.hk
      • Sub-Investigator: Po Tai CHAN, PhD
      • Sub-Investigator: Wei Han HUI, MBBS
      • Sub-Investigator: Albert Kit Yu NG, MBBS
      • Sub-Investigator: Hoi Wa NG, MSc
      • Sub-Investigator: Ha Kan CHU, MSc
      • Sub-Investigator: Lisa Pau Le LOW, PhD
      • Principal Investigator: Hau Kim CHOY, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; no intervention
Experimental: message-based lifestyle intervention; The intervention group will receive 4 mobile phone messages per week for 24 weeks.	Behavioral: Message-based lifestyle intervention; Peripheral artery disease patients who have received revascularization in the past 6 months, are randomized into 2 groups. The total sample size will be 160. Both intervention and control groups will receive face-to-face lifestyle adherence counseling and booklets at baseline. The intervention group will receive 4 mobile phone messages per week for 24 weeks. The messages are motivational advice to support lifestyle behavioral modification in various stages of behavioral changes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change of Readiness for behavioural changes	Measured by Patient Activation Measure	Change from baseline, 6- week and 6-month follow-up
Change of Health related Quality of life	Measured by SF12v2	Change from baseline, 6- week and 6-month follow-up
Change of BMI	Body Mas Index	Change from baseline, 6- week and 6-month follow-up
Change of ABI	Ankle-Brachial Index	Change from baseline, 6- week and 6-month follow-up
Change of Fasting glucose level	Fasting glucose level	Change from baseline and 6-month follow-up
Change of HDL level	HDL level	Change from baseline and 6-month follow-up
Change of Total cholesterol level	Total cholesterol level	Change from baseline and 6-month follow-up

Collaborators and Investigators

• Sponsor: Caritas Institute of Higher Education
• Investigators: Principal Investigator: Hau Kim CHOY, MSc, Caritas Institute of Higher Education

Publications and helpful links

General Publications

• 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. doi: 10.1097/00005650-199603000-00003.
• 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, Walsh ME. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Mar 21;135(12):e686-e725. doi: 10.1161/CIR.0000000000000470. Epub 2016 Nov 13. Erratum In: Circulation. 2017 Mar 21;135(12 ):e790.
• Hankey GJ, Norman PE, Eikelboom JW. Medical treatment of peripheral arterial disease. JAMA. 2006 Feb 1;295(5):547-53. doi: 10.1001/jama.295.5.547.
• European Stroke Organisation; Tendera M, Aboyans V, Bartelink ML, Baumgartner I, Clement 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, Rother J, Sievert H, van Sambeek M, Zeller T; ESC Committee for Practice Guidelines. ESC Guidelines on the diagnosis and treatment of peripheral artery diseases: Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2011 Nov;32(22):2851-906. doi: 10.1093/eurheartj/ehr211. Epub 2011 Aug 26. No abstract available.
• Rantner B, Kollerits B, Pohlhammer J, Stadler M, Lamina C, Peric S, Klein-Weigel P, Muhlthaler 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 Apr 3;8:45833. doi: 10.1038/srep45833.
• 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. doi: 10.1016/j.ejvs.2004.09.020.
• 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.110.983536. Epub 2011 May 16.
• 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.
• 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 Coronary Heart Disease: A Randomized Clinical Trial. JAMA. 2015 Sep 22-29;314(12):1255-63. doi: 10.1001/jama.2015.10945. Erratum In: JAMA. 2016 Mar 8;315(10):1057.
• 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. doi: 10.2196/jmir.4944.
• Hong Kong Census and Statistics Department: Information Technology usage 2016. Retrieved from https://www.censtatd.gov.hk/hkstat/sub/gender/itu/index.jsp.
• Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997 Sep-Oct;12(1):38-48. doi: 10.4278/0890-1171-12.1.38.
• Cohen J. Statistical power analyses for the social sciences. Hillsdale, NJ, Lawrence Erlbauni Associates. 1988.
• Wagner III WE. Using IBM® SPSS® statistics for research methods and social science statistics. Sage Publications; 2014 Mar 20.
• 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. doi: 10.1111/j.1475-6773.2004.00269.x.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 17, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Rehabilitation; Peripheral artery disease; Mobile phone text message
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: HRE170101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No