Digital health interventions to promote healthy lifestyle in hemodialysis patients: an interventional pilot study

Study design

This study was a trial utilizing pretest–posttest design. The study protocol was approved by the Research Ethics Committee of National Taiwan University Hospital (No. 201812145RINA). The ClinicalTrials.gov number was NCT05281497]. Written informed consent was obtained from all participants before starting the study. All methods were performed in accordance with the relevant guidelines and regulations (the Declaration of Helsinki). The first trial registration was on 01/07/2019.

Study population

This study prospectively enrolled ESRD patients undergoing HD from the HD center of National Taiwan University Hospital (NTUH) Yunlin branch and Ming-De HD clinic between July 2019 and December 2019. The NTUH Yunlin branch is a regional teaching hospital located in a suburban area in mid-Taiwan. The Ming-De HD clinic is a HD clinic with 41 beds for stable HD patients. The patients underwent thrice-weekly standard bicarbonate HD, with a target Kt/V of at least 1.2 using single-use dialyzers with high-efficiency or high-flux membranes¹⁸. Patient inclusion criteria were aged 20 years and above with a diagnosis of ESRD and having received HD maintenance for more than 3 months. Those who agreed to participate in the study signed informed consent forms. Exclusion criteria were an inability to use a smartphone, impaired walking capacity or a psychiatric disorder, or any hospitalization during the previous 3 months. If the participants changed dialysis modality or received renal transplantation during the study period, they would be excluded because of incomplete interventions.

Data collection

All participants undertook a brief interview to document their demographic profiles. The diagnosis of comorbidity was documented by clinically relevant histories or medical examinations. Because HD patients had high cardiovascular risk and reduced exercise tolerance, a Physical Activity Readiness Questionnaire (PAR-Q)¹⁹ was performed before the intervention. PAR-Q offered a safe preliminary screening of candidates for exercise testing and prescription. Laboratory data including hemograms and serum biochemistry, were measured as per the care routine for ESRD patients according to the guidelines of the Taiwan Society of Nephrology. All blood samples were drawn before dialysis before the first HD session in the week.

Description of the intervention

The researchers included a nephrologist and her assistants, who were from graduate school of health industry management in National Yunlin University of Science and Technology. They were also supervised by physical therapists and dietitians. Each participant was provided with a wearable device (a Heart Rate Smart Wristband, GSH405-B6, Golden Smart Home Technology Corporation) (Fig. 1). The wristband was approved by the National Communications Commission of Taiwan (NCC verification code: CCAB16LP1430T3). The device could detect steps (0–120,000 steps, division 1 step), calories, and sleep periods. The wearable device was validated in previous studies^17,20.

Heart Rate Smart Wristband, GSH405-B6, Golden Smart Home Technology Corporation.

Each participant downloaded an app (WowGoHealth app) (Fig. 2) to connect with the health management platform (GSH AI health platform). Participants’ exercise-related data, including number of steps walked, distance, consumed calories, and heart rate, were collected through the wearable devices. All participants were taught to record a dietary diary by taking photos of meals and using a smartphone application. All collected information was uploaded to the health management platform. Only the researchers could access the data on the health management platform. The researchers analyzed the pictures every day with average 3–5 pictures to calculate the calories and nutrients in the food, such as starches, proteins, and lipids, and the percentage of vegetables and fruits. The researchers made suggestions about diet to the participants.

User interface of the health management platform software (WowGoHealth App).

Exercise included an 18-min calisthenics program made by the Health Promotion Administration, Ministry of Health and Welfare (Fig. 3). The video included stretching, aerobic and resistance training, and could be performed in a sitting or standing position. Participants were asked to perform the calisthenics at least three times a week. A daily step count of 7500 steps was set according to a prospective cohort study which revealed that mortality rates progressively decreased before leveling off at approximately 7500 steps per day²¹.

(Adapted from the official website: https://youtube.com/user/hpagov).

An 18-min calisthenics video made by the Health Promotion Administration, Ministry of Health and Welfare Mandarin Version: https://youtu.be/_w50TfdCmKU; Hokkien Version: https://youtu.be/-Otr4BlYm2E

LINE is a mobile app operated by the LINE Corporation. All users can use texts, images, videos, and audio for communication at any time. In Taiwan, LINE is the predominant text messaging app. A LINE group was created to inspire the participants, especially when the daily target step count had been reached. Teleconsultations of health information were provided via LINE. All the interventions lasted for 24 weeks.

Outcome measurement instruments

All outcome measures were collected at baseline, and weeks 4, 8, 12, 16 and 24 after initiation of the study.

Primary outcomes

Sit-to-stand-10 (STS-10) tests measured the time taken to complete 10 sit-to-stand cycles. Participants were instructed to start and finish the test in a seated position on a standard chair which was positioned against a wall. Patients stood from a seated position and sat back down again as quickly as possible, with their arms folded across their chest. The time taken to perform 10 repetitions was recorded²². Sit-to-stand-60 (STS-60) measured the number of repetitions of sit-to-stand cycles achieved in 60 s²³. The STS-10 and STS-60 were suitable for measuring lower extremity muscle strength and had high test–retest reliability in ESRD patients²³.

The 6-min walk test (6MWT) was used as an index of exercise capacity. The 6MWT was performed according to the statements of the American Thoracic Society²⁴. Participants were instructed to walk as fast as they could for 6 min on a flat 30-m track. They were allowed to stop and rest during the test but were instructed to resume walking as soon as they felt able to do so. The distance walked was recorded²³.

Hand grip strength (HGS) was an easily performed test and correlated well with lean body mass in ESRD patients²⁵. It was an independent outcome predictor of male ESRD patients²⁶. A handgrip dynamometer (CAMRY digital hand dynamometer EH101, Fig. 4) was used to measure the amount of strength developed by each hand. The device could capture the electronic hand grip automatically. It provided excellent reliability and validity as Jamar dynamometer, which was a widely recognized tool for measuring grip strength²⁷. The participants performed STS-10, STS-60, 6MWT and HGS before the third HD session of the week.

CAMRY digital hand dynamometer EH101 was used to measure the hand grip strength developed by each hand.

Secondary outcomes

HRQoL was measured by the Kidney Disease Quality of Life survey (KDQOL-36™)²⁸. The KDQOL-36™ was a short form that includes the 12-Item Short Form Survey (SF-12) as a generic core plus the burden of kidney disease, symptoms/problems of kidney disease, and effects of kidney disease scales from the KDQOL-SF™ v1.3. Items 1–12 were SF-12; items 13–16 were burden of kidney disease; items 17–28 were symptoms/problems; while items 29–36 were effects of kidney disease. The higher the scores, the better the HRQoL. The Cronbach’s alpha was estimated in excess of 0.8²⁸.

The Subjective Global Assessment (SGA) was a reliable tool for the evaluation of nutritional status and for detection of protein-energy wasting (PEW) in dialysis patients²⁹. The 7-point SGA scored according to the patients’ history of weight change in the previous 6 months, dietary intake, and presence of gastro-intestinal symptoms (loss of appetite, nausea, vomiting, and diarrhea). A physical examination of loss of subcutaneous fat mass and muscle wasting was conducted. A score of 6–7 indicated a normal nutritional status, a score of 3–5 indicated mild to moderate PEW, and a score of 1–2 indicated severe PEW³⁰.

Statistical analysis

Statistical analyses were performed using IBM SPSS Statistics for Windows, version 22.0.0 (IBM Corporation), and a 2-sided P value < 0.05 was considered significant. We examined the distribution of all outcome data. The distributional properties of the data were expressed as mean ± standard deviation for continuous variables with a normal distribution or median (interquartile range) for those with a skewed distribution. The repeated measures ANOVA was used to compare the outcomes, and F test with Greenhouse–Geisser adjustment (F-GG) was used to correct the degrees of freedom of the F-distribution³¹. For categorical variables with percentages (%), a chi-square or Fisher’s exact test was used. Pearson or Spearman correlation (normal or non-normal distribution, respectively) was used for analysis of association of monthly step count with the physical function, HRQoL, SGA, and laboratory data.

Ethics approval and consent to participate

The study is approved by National Taiwan University Hospital’s Research Ethics Committee (No. 201812145RINA), and informed consent was acquired from all participants. The ClinicalTrials.gov number was NCT05281497. The first trial registration was on 01/07/2019.