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

NCT03640767 | Unknown

• 1 other identifier: HRE170101
• Study Type: interventional
• Target: 160
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Message-based Rehabilitation for Peripheral Artery Disease Patients

Keywords

Rehabilitation; Peripheral artery disease; Mobile phone text message

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change of Smoking status

  Change from baseline, 6- week and 6-month follow-up

• Change of Readiness for behavioural changes

  Change from baseline, 6- week and 6-month follow-up

• Change of Health related Quality of life

  Change from baseline, 6- week and 6-month follow-up

• Change of BMI

  Change from baseline, 6- week and 6-month follow-up

• Change of ABI

  Change from baseline, 6- week and 6-month follow-up

Study Arms (2)

message-based lifestyle intervention

EXPERIMENTAL

The intervention group will receive 4 mobile phone messages per week for 24 weeks.

Behavioral: Message-based lifestyle intervention

Control

NO INTERVENTION

no intervention

Interventions

Message-based lifestyle intervention BEHAVIORAL

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.

message-based lifestyle intervention

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Refuse to provide an informed-consent form. Clinical diagnosis of lack of capacity to provide informed consent.

Sponsors & Collaborators

• Caritas Institute of Higher Education: lead

Study Sites (2)

Choy Hau Kim

Hong Kong, China

RECRUITING

Choy Hau Kim

Hong Kong, HK, HK, Hong Kong

RECRUITING

Related Publications (15)

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MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Hau Kim CHOY, MSc

  Caritas Institute of Higher Education

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hau Kim CHOY, MSc

CONTACT

852 3702 4262; hkchoy@cihe.edu.hk

Hoi Wa NG, MSc

CONTACT

+852 63808505; nhw716@ha.org.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 21, 2018
• Study Start: December 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: June 30, 2020
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); HK (1)