Mobile health-based remote interaction management intervention for patients with low anterior resection syndrome: study protocol for a randomised controlled trial

Introduction Low anterior resection syndrome (LARS) involves bowel dysfunction after sphincter-preserving surgery for rectal resection that significantly impacts patients’ quality of life (QoL). The improvement of LARS largely depends on patient self-management behaviour; however, insufficient infor...

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Main Authors: Ting Wang, Peng Zhou, Min Fu, Shihui Yu, Shaohua Hu, Hongye He, Xueying Pang, Danqiao Yin, Degang Zhu
Format: Article
Language:English
Published: BMJ Publishing Group 2022-12-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/12/12/e066046.full
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author Ting Wang
Peng Zhou
Min Fu
Shihui Yu
Shaohua Hu
Hongye He
Xueying Pang
Danqiao Yin
Degang Zhu
author_facet Ting Wang
Peng Zhou
Min Fu
Shihui Yu
Shaohua Hu
Hongye He
Xueying Pang
Danqiao Yin
Degang Zhu
author_sort Ting Wang
collection DOAJ
description Introduction Low anterior resection syndrome (LARS) involves bowel dysfunction after sphincter-preserving surgery for rectal resection that significantly impacts patients’ quality of life (QoL). The improvement of LARS largely depends on patient self-management behaviour; however, insufficient information about supportive care and weak awareness of self-management lead to poor self-management behaviour. Motivational interviewing (MIs) explore and change patients’ ambivalence during the conversation, thereby changing and maintaining healthy behaviours to enhance effective participation. In recent years, mobile health has been widely used in clinical practice, providing continuous information support and remote interaction. However, current online information on LARS is suboptimal, websites are highly variable, important content is often lacking and the material is too complex for patients. Therefore, this study will evaluate the impacts of a remote LARS interaction management intervention based on a WeChat applet (‘e-bowel safety’) and MIs on patients with LARS.Methods and analysis This study will be a single-blind, two-arm randomised controlled trial involving patients with LARS in three tertiary grade A general hospitals who will be randomised into two groups. The intervention group will use the ‘e-bowel safety’ applet and the intervention team will conduct a monthly MI about syndrome management. The control group will receive an information booklet that contains the same information as that provided in the ‘e-bowel safety’ informational module. The intervention will last for 3 months, followed by 3 months of follow-up. The primary outcome will be global QoL; the secondary outcomes will include bowel function, social support, self-management measured at the baseline, 3 months and 6 months for three times and patients’ thinkings at the end of the intervention (at 3 months).Ethics and dissemination Ethics approval was granted by the Clinical Medical Research Ethics Committee of the First Affiliated Hospital of Anhui Medical University (PJ2022-07-53).Trial registration number Chinese Clinical Trial Registry (ChiCTR2200061317).
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spelling doaj-art-3532bd74771f40aaa2d4bb121d0509b82025-08-20T02:16:03ZengBMJ Publishing GroupBMJ Open2044-60552022-12-01121210.1136/bmjopen-2022-066046Mobile health-based remote interaction management intervention for patients with low anterior resection syndrome: study protocol for a randomised controlled trialTing Wang0Peng Zhou1Min Fu2Shihui Yu3Shaohua Hu4Hongye He5Xueying Pang6Danqiao Yin7Degang Zhu8Fudan University School of Public Health, Fudan University, Shanghai, Shanghai, China1 Department of Neurology, Institute of Neuroscience, Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, the Second Affiliated Hospital, Guangzhou Medical University, Guangzhou 510260, China1 Department of Gastrointestinal Surgery, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China4 KingMed School of Laboratory Medicine, Guangzhou Medical University, Guangzhou, Guangdong, China4 Department of Nursing, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China1 Department of Gastrointestinal Surgery, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China1 Department of Gastrointestinal Surgery, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China2 School of Nursing, Anhui Medical University, Hefei, Anhui, China3 Department of Information, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, ChinaIntroduction Low anterior resection syndrome (LARS) involves bowel dysfunction after sphincter-preserving surgery for rectal resection that significantly impacts patients’ quality of life (QoL). The improvement of LARS largely depends on patient self-management behaviour; however, insufficient information about supportive care and weak awareness of self-management lead to poor self-management behaviour. Motivational interviewing (MIs) explore and change patients’ ambivalence during the conversation, thereby changing and maintaining healthy behaviours to enhance effective participation. In recent years, mobile health has been widely used in clinical practice, providing continuous information support and remote interaction. However, current online information on LARS is suboptimal, websites are highly variable, important content is often lacking and the material is too complex for patients. Therefore, this study will evaluate the impacts of a remote LARS interaction management intervention based on a WeChat applet (‘e-bowel safety’) and MIs on patients with LARS.Methods and analysis This study will be a single-blind, two-arm randomised controlled trial involving patients with LARS in three tertiary grade A general hospitals who will be randomised into two groups. The intervention group will use the ‘e-bowel safety’ applet and the intervention team will conduct a monthly MI about syndrome management. The control group will receive an information booklet that contains the same information as that provided in the ‘e-bowel safety’ informational module. The intervention will last for 3 months, followed by 3 months of follow-up. The primary outcome will be global QoL; the secondary outcomes will include bowel function, social support, self-management measured at the baseline, 3 months and 6 months for three times and patients’ thinkings at the end of the intervention (at 3 months).Ethics and dissemination Ethics approval was granted by the Clinical Medical Research Ethics Committee of the First Affiliated Hospital of Anhui Medical University (PJ2022-07-53).Trial registration number Chinese Clinical Trial Registry (ChiCTR2200061317).https://bmjopen.bmj.com/content/12/12/e066046.full
spellingShingle Ting Wang
Peng Zhou
Min Fu
Shihui Yu
Shaohua Hu
Hongye He
Xueying Pang
Danqiao Yin
Degang Zhu
Mobile health-based remote interaction management intervention for patients with low anterior resection syndrome: study protocol for a randomised controlled trial
BMJ Open
title Mobile health-based remote interaction management intervention for patients with low anterior resection syndrome: study protocol for a randomised controlled trial
title_full Mobile health-based remote interaction management intervention for patients with low anterior resection syndrome: study protocol for a randomised controlled trial
title_fullStr Mobile health-based remote interaction management intervention for patients with low anterior resection syndrome: study protocol for a randomised controlled trial
title_full_unstemmed Mobile health-based remote interaction management intervention for patients with low anterior resection syndrome: study protocol for a randomised controlled trial
title_short Mobile health-based remote interaction management intervention for patients with low anterior resection syndrome: study protocol for a randomised controlled trial
title_sort mobile health based remote interaction management intervention for patients with low anterior resection syndrome study protocol for a randomised controlled trial
url https://bmjopen.bmj.com/content/12/12/e066046.full
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