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Table 2 Characteristic of included studies of the validation process

From: Digital symptom management interventions for people with chronic kidney disease: a scoping review based on the UK Medical Research Council Framework

Type in the MRC framework

Study ID

Country

AIM

Population

Study design

Description of intervention

Result/ outcome measure in protocol

Feasibility Study

(Burrows et al., 2023)

USA

To assess the feasibility and preliminary efficacy of a VRM program combined with PARx in HD patients with elevated depressive symptoms.

10 HD patients (mean age 59.60 ± 13.66, 60% African American, 70% female) with elevated depressive symptoms.

Randomized control trial

2-week prehabilitation with VRM + PARx or usual care, followed by an 8-week PARx program for both groups, including VR-based mindfulness and various physical activities.

25% recruitment rate, 90% retention, 75% exercise adherence. improved mindfulness (+), reduced depressive symptoms (+); physical activity energy expenditure (-), between groups, fatigue (-)

Efficacy study

(Nelson et al., 2018)

USA

To examine the efficacy of a home-based kidney care program in rural adult Zuni Indians with CKD, focusing on its impact on patient activation and CKD risk factors.

98 rural adult Zuni Indians with Chronic Kidney Disease, selected from a cohort of 1416 individuals.

Randomized control trial

A 12-month home-based kidney care program, including initial lifestyle coaching and frequent additional reinforcement by community health representatives. The intervention focused on adherence to medicines, diet, exercise, self-monitoring, and coping strategies for living with stress (including distributing pamphlets and motivational messages via smartphone).

improvement in patient activation scores (+), decline in BMI (+), reduction in haemoglobin A1c (+), 3.3-fold decrease in high-sensitivity C-reactive protein (+), a 5-point increase in the Short-Form 12 Health Survey mental score (+).

Efficacy study

(Fallahpour et al., 2020)

Iran

To evaluate the effects of telephone-based telenursing on perceived stressors in older adults undergoing hemodialysis.

Sixty older adults receiving hemodialysis at Shahid Beheshti and Imam Khomeini hospitals in Babol and Behshahr, Iran.

Quasi‑experimental study

A 3-month telephone-based telenursing program, including educational sessions and follow-up telephone contacts focusing on health status and educational needs.

Significant reduction in mean scores of both physiological and psychosocial stressors(+)

Efficacy study

(Cho & Sohng, 2014)

South Korea

To investigate the effects of a virtual reality exercise program (VREP) on physical fitness, body composition, and fatigue in hemodialysis patients.

Hemodialysis patients with end-stage renal failure.

Nonequivalent control group pretest-posttest design

VREP using Nintendo’s Wii Fit Plus for 40 min, 3 times a week for 8 weeks.

Increased physical fitness and body composition (+), significantly decreased fatigue (+) in the exercise group

Development + Feasibility Study

(Eaton et al., 2020)

USA

To promote objectively measured antihypertension medication adherence in adolescents and young adults (AYAs) with chronic kidney disease (CKD) using a mobile health (mHealth) messaging intervention.

34 AYAs with CKD, primarily male and White, without a hypertension diagnosis, taking an angiotensin-converting enzyme inhibitor once a day.

Pilot randomized controlled trial + qualitative interviews

A Reminder + COM-B (Capability, Opportunity, Motivation – Behavior) Message intervention with text messages sent at the same frequency and order to all participants.

daily adherence in the intervention group remained relatively stable with some improvement over time (-)

Feasibility and usability study

(Hayashi et al., 2017)

Japan

To evaluate the feasibility and usability of the Self-Management and Recording System for Dialysis (SMART-D), a smartphone-based self-management support system for dialysis patients.

Nine hemodialysis patients at two outpatient facilities in Tokyo, who had been receiving outpatient hemodialysis treatment for at least 2 years and were aged 20 years or older.

Questionnaire interview

SMART-D system that allows patients to record body weight, predialysis serum potassium and phosphorus concentrations, and displays data graphically against target values via smartphone APP.

High completion rates for recording data: 89% for body weight, 95% for predialysis/post-dialysis weight, and 78% for serum potassium and phosphorus concentrations. Positive feedback on usability and impact on self-management.

Efficacy study

(Gross et al., 2017)

USA

Evaluate the effectiveness of telephone-adapted Mindfulness-based Stress Reduction (tMBSR) in transplant candidates

Patients awaiting kidney transplantation

randomized, active-controlled, open-label trial

An 8-week program of meditation and yoga delivered through teleconferences and in-person workshops, compared to a telephone-based support group

No significant reduction in anxiety (-), but improvement in mental health-related quality of life (+)

Feasibility Study

(Reilly-Spong et al., 2015)

USA

To assess the feasibility of a telephone-adapted mindfulness-based stress reduction (tMBSR) program for kidney transplant candidates

63 kidney transplant candidates

Randomized controlled trial

An adapted 8-week MBSR program delivered via two in-person workshops and six weekly teleconferences compared to a telephone-based support group (tSupport)

High participation, satisfaction and high fidelity with intervention.

Feasibility and acceptability study

(Jakubowski et al., 2020)

USA

Pilot feasibility and acceptability of technology-assisted CBT intervention in ESRD patients on hemodialysis

Adult ESRD patients on hemodialysis

Single-center pilot feasibility study

8 sessions of CBT therapy for depression, pain, or fatigue, conducted via video-conferencing during hemodialysis sessions

No significant changes in depression, fatigue or pain (-), a small improvement in the SF-36 Physical Component score (+)

Feasibility study

(Hudson et al., 2017)

UK

Assess the feasibility of online CBT for haemodialysis patients

Adults on haemodialysis with psychological distress

Two-arm parallel group feasibility randomised controlled trial

Online CBT tailored for haemodialysis patients, with or without therapist support calls

No significant difference in psychological distress outcomes (-)

Feasibility study (protocol)

(Sandys et al., 2022)

Ireland

Evaluate the utility and acceptability of a wearable hydration monitor in hemodialysis patients

20 haemodialysis patients (estimated)

Pilot-scale single-arm observational study

Use of a wearable hydration monitor, the Sixty device, to measure fluid levels during hemodialysis

ultrafiltration millilitres,

blood pressure,

blood volume,

acceptability

Feasibility study

(Dawson, Tong, et al., 2021)

Australia

Evaluate the feasibility and impact of mobile phone text messages to alter dietary behaviours in people on haemodialysis

25 adult patients on maintenance haemodialysis

Semi-structured interviews

Mobile phone text messaging targeting dietary behaviours in haemodialysis patients

Text messaging was found to be acceptable for improving dietary behaviours.

Efficacy study

(Ni et al., 2019)

China

Evaluate the impact of a telehealth-based dialysis registration system on renal anaemia control

Patients with ESRD undergoing MHD

Multicenter study

Development of a dialysis registration system based on the WeChat mobile platform for recording and monitoring haemoglobin and hematocrit levels, allowing physicians to treat anaemia appropriately

the detection rate of haemoglobin increased

the target rate of haemoglobin from 47.55–56.07%

mean haemoglobin level increased

Efficacy study

(Torabikhah et al., 2023)

Iran

To compare the effects of a mobile health (mHealth) application based on the micro-learning method in patients undergoing hemodialysis.

Seventy patients undergoing hemodialysis.

Single-blind randomized clinical trial.

The mHealth group used an app with 3-minute educational videos on topics like HD management, complications, dietary recommendations, fluid intake, physical activities, vascular access care, and medication use. Face-to-face training covered similar content but was delivered in person. Both interventions lasted one month.

significant improvement in adherence to medication therapy(+)

Efficacy study

(Kargar Jahromi et al., 2015)

Iran

To evaluate the effect of nurse-led telephone follow-ups (tele-nursing) on depression, anxiety, and stress in hemodialysis patients.

60 patients with advanced chronic renal disease treated with hemodialysis.

Double-blind randomized clinical trial.

Each telephone session lasted 30 min, discussing key subjects like communication, cognition, breathing/circulation, nutrition, sleep, pain, and psychosocial aspects.

significant improvements in depression, anxiety, and stress scores (+)

Efficacy study

(Li et al., 2014)

China

To evaluate the effect of post-discharge nurse-led telephone support on patients with chronic kidney disease undergoing peritoneal dialysis.

160 patients undergoing peritoneal dialysis.

Randomized controlled trial.

The intervention group received comprehensive discharge planning and 6-week post-discharge nurse-led telephone support.

Significant improvements in quality of life dimensions like sleep, staff encouragement, and pain (+)

reduced 12-week clinic visit rates (+).

Feasibility and acceptability study (protocol)

(Duncanson et al., 2020)

Australia

To evaluate the feasibility and acceptability of e-PROMs data capture and feedback in haemodialysis

Patients receiving haemodialysis, nurses, nephrologists

Qualitative evaluation of the pilot

e-PROMs data capture and feedback in the SWIFT pilot, including symptom monitoring with feedback to clinicians embedded within ANZDATA.

NA

Feasibility and acceptability study

(Hernandez et al., 2018)

USA

To determine the feasibility and acceptability of an Internet-based positive psychological intervention in hemodialysis patients with comorbid depressive symptoms

Hemodialysis patients with depressive symptoms

Single-arm pre-post trial

A 5-week internet-based positive psychological intervention using tablets. Skills targeted included gratitude, mindfulness, positive reappraisal, and kindness.

Significant improvements in depressive symptoms score reduced (+).

Feasibility study

(Agarwal et al., 2023)

Australia

Evaluate the feasibility of e-PROMs for hemodialysis patients with feedback to clinicians

Adults receiving hemodialysis

Registry-based cluster randomized pilot

Electronic symptom monitoring using e-PROMs, including the Integrated Palliative Outcomes Scale-Renal (IPOS-Renal) and EuroQOL 5 dimensions 5 levels (EQ-5D-5 L), with feedback to treating teams every 3 months.

Successful deployment of e-PROMs with a response rate of 71%. Improvements were noted in quality of life and symptom burden scores, as well as the EQ-5D-5 L (+)

Feasibility study

(Flythe et al., 2020)

USA

To assess the feasibility of tablet-based patient-reported symptom data collection among hemodialysis patients

62 hemodialysis patient participants, 19 care team participants and 32 research participants.

Mixed method study

Implementation of a tablet-based electronic patient-reported outcome measure (ePROM) for symptom tracking during hemodialysis.

High ePROM completion rate (84%), improved symptom awareness (+), and patient-care team communication.

Efficacy study

(A. Hosseini et al., 2023)

Iran

To determine the effect of an educational app on hemodialysis patients’ self-efficacy and self-care

60 patients undergoing hemodialysis

Quasi-experimental longitudinal single-group study

Educational application used by patients to complete questionnaires on self-efficacy and self-care

Significant improvements in self-care behaviours and self-efficacy (+)

Efficacy study

(Turoń-Skrzypińska et al., 2023)

Poland

Assess the relationship between regular physical activity with virtual reality and symptoms of anxiety and depression in hemodialysis patients

85 hemodialysis patients at the Department of Nephrology Transplantology and Internal Medicine PUM

Randomized controlled trial

VR exercises using the prototype of the NefroVR system for 20 min during hemodialysis sessions, three times a week

Significant decrease in anxiety and depression symptoms(+)

Feasibility study

(Brys et al., 2021)

The Netherlands

To gain an in-depth understanding of haemodialysis (HD) patients’ diurnal fatigue patterns and related variables using a mobile Health (mHealth) experience sampling methodology (ESM) application

40 HD patients

Prospective observational study using mHealth ESM application for 7 days

Assessing momentary fatigue and related variables (daily activities, self-reported physical activity, social company, location, and mood) using mHealth ESM application

Fatigue varied between and within individuals and was significantly related to HD treatment days, type of daily activity, mood, and sleep quality

Acceptability and utility study

(Hernandez et al., 2021)

USA

To test the safety, acceptability, and utility of a virtual reality (VR) program in hemodialysis treatment sessions

20 hemodialysis patients

Phase 1 single-arm proof-of-concept trial

25-minute mindfulness/meditation program using Oculus Rift, administered during hemodialysis

Significant decrease in treatment/motion-related symptoms post-VR exposure; high levels of immersion; software rated easy to operate

Efficacy study

(Torabikhah et al., 2023)

Iran

Comparing mHealth app and face-to-face training effects on dietary/fluid intake adherence in hemodialysis patients

70 hemodialysis patients

Single-blinded two-stage/two-group randomized clinical trial

mHealth app (Di Care) and face-to-face training interventions

improvement in clinical/laboratory parameters (+); both interventions improved adherence (+)

Efficacy study

(Fakih El Khoury et al., 2020)

United Arab Emirates

To evaluate the efficacy of a dietary mobile app (KELA.AE) for improving dietary intakes in hemodialysis patients

23 hemodialysis patients

Prospective pilot study

Use of the KELA.AE mobile app, providing educational materials and self-monitoring features for diet tracking

Improvement in energy, protein and biological value food intakes (+)

Efficacy study

(T. Hosseini et al., 2024)

Iran

To evaluate the effect of using VR contents on anxiety in hemodialysis patients undergoing surgical interventions

30 hemodialysis patients

Non-equivalent groups pre-posttest quasi-experimental study

Virtual reality exposure therapy using VR content simulating real surgical experiences

Significant reduction in state and trait anxiety (+)

  1. ‘(+)’ means positive outcome, while ‘(-)’ means negative outcome