Administrative information
Title {1} | E-HEalth treatment in Long-term Dialysis (E-HELD): study protocol for a multicenter randomized controlled trial evaluating Internet-based cognitive-behavioral therapy in dialysis patients |
Trial registration {2a and 2b} | Netherlands Trial Register (NL7160). Registered on July 16, 2018. |
Protocol version {3} | Version 7.0. Date: January 29, 2020. |
Funding {4} | This work was supported by the Dutch Kidney Foundation (SWO 16.07). |
Author details {5a}c | Judith Tommel, Health, Medical and Neuropsychology unit, Institute of Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, the Netherlands. Andrea W. M. Evers, Health, Medical and Neuropsychology unit, Institute of Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, the Netherlands. Henk W. van Hamersvelt, Department of Nephrology, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, the Netherlands. Sandra van Dijk, Health, Medical and Neuropsychology unit, Institute of Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, the Netherlands. Niels H. Chavannes, Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands. Lieke Wirken, Health, Medical and Neuropsychology unit, Institute of Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, the Netherlands. Luuk B. Hilbrands, Department of Nephrology, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, the Netherlands. Henriët van Middendorp, Health, Medical and Neuropsychology unit, Institute of Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, the Netherlands. |
Name and contact information for the trial sponsor {5b} | Health, Medical and Neuropsychology unit, Institute of Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Wassenaarseweg 52, 2333 AK Leiden, the Netherlands |
Role of sponsor {5c} | The funder and sponsor played no role in the design of the study, the collection, management, analysis, and interpretation of data and in writing the manuscript. |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions and outcomes
Study setting {9}
Eligibility criteria {10}
Inclusion and exclusion criteria
Screening of adjustment problems
Domain | Measure | Explanation | Scale | Study period | ||
---|---|---|---|---|---|---|
Baseline + screening | 6-month follow-up | 12-month follow-up | ||||
Primary outcome | ||||||
Distress | Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) [45] | Composite measure of depression and anxiety. | 0–48, higher scores indicate more symptoms of depression and anxiety, cut off: 0–9 minimal, 10–19 mild, 20–29 moderate, 30–48 severe. | X | X | X |
Secondary outcomes | ||||||
Personalized outcome assessment | Patient Priority and Progress Questionnaire (PPPQ) [46] | Patient priorities and personal meaningful changes over time. Measured by 1 item on priorities and 8 items on functioning using 5-point Likert scales for the baseline measurement and 7-point Likert scales for the follow-up measurement. Based on the follow-up measurement, a progress score is calculated on the selected priority. | −3–3, progress score, higher scores indicate subjective improvement on the selected priority as compared to the baseline measurement. | X | X | X |
Domains of functioning | RAND Short Form-36 Health Status Inventory (RAND SF-36) [47] | Health-related quality of life, including physical and mental component scores. Measured by 36 items using several Likert scales and yes/no questions. | T-scores, M=50±10 in the general population. | X | X | X |
Dialysis Symptom Index (DSI) [48] | Physical and emotional symptom burden in dialysis patients. 30 items regarding the presence of symptoms, when present symptom severity is assessed by 5-point Likert scales. | 30 yes/no questions, if “yes” 1=not at all, 5=very much. Minimum score is 0 when none of the symptoms are reported. Maximum score is 150 when all 30 symptoms are reported and rated as “bothers very much” (Likert scale score 5). | X | X | X | |
Subjective experience of fatigue subscale, Checklist Individual Strength (CIS) [49] | Fatigue. Measured by 8 items using 7-point Likert scales. | 8–56, higher scores indicate more fatigue. | X | X | X | |
Itch subscale of the Impact of Chronic Skin Disease on Daily Life (ISDL) [50] | Itch. Measured by 4 items including 3 items using 4-point Likert scales and 1 VAS (0 = no itch, 10 = worst itch ever). | 4–16, the 11-point VAS will be transformed into a 4-point Likert scale to assess the total score. Higher scores indicate more itch. | X | X | X | |
Inventory for Social Resilience (ISR) [51] | Social functioning. Measured by the subscales perceived support (5 items), actual support (3 items), and mutual visits (2 items) using 4-point Likert scales. | 5–20, perceived support. 2–13, actual support. 2–8, mutual visits. Higher scores indicate better social functioning. | X | X | X | |
Lifestyle behavior | Lifestyle behavior. Measured by 5 items using 4-point Likert scales, 2 yes/no questions, and 2 open questions to report height and weight. | 7–48, total score of the 5 4-point Likert scale items and the 2 yes/no questions (2 yes/no questions are transformed to 4-point Likert scales). Higher scores indicate better lifestyle behaviors. BMI will be calculated using the patients’ height and weight, ≤18.5 underweight, 18.5–24.9 healthy weight, 25.0–29.9 overweight, ≥30.0 obese. | X | X | X | |
Psychological parameters | Self-Efficacy for Managing Chronic Disease 6-ltem Scale (SEMCD-6) [52] | Self-efficacy. Measured by 6 items using 10-point Likert scales. | 6–60, higher scores indicate better self-efficacy. | X | X | X |
Partners in Health Scale (PiH) [53] | Chronic condition self-management knowledge and behaviors, version adjusted to chronic kidney disease. Measured by 13 items using 9-point Likert scales. | 0–104, higher scores indicate better self-management. | X | X | X | |
Illness Cognition Questionnaire (ICQ) [54] | Illness cognitions. Measured by the subscales helplessness (6 items), acceptance (6 items), and perceived benefits (6 items) using 4-point Likert scales. | 1–24, helplessness. 1–24, acceptance. 1–24, perceived benefits. Higher scores indicate higher levels of the illness cognitions. | X | X | X | |
Life Orientation Test – Revised (LOT-R) [55] | Optimism. Measured by 3 items on optimism, 3 items on pessimism, and 4 filler items using 5-point Likert scales. | 0–12, 3-item optimism subscale, higher scores indicate more optimism. 0–12, 3-item pessimism subscale, higher scores indicate more pessimism. 0–24, total score 6 items, higher scores indicate more optimism. | X | X | X | |
Extraversion. Measured by 12 yes/no questions. Neuroticism. Measured by 12 yes/no questions. | 0–12, extraversion, higher scores indicate more extraversion. 0–12, neuroticism, higher scores indicate more neuroticism. | X | X | X | ||
Internet-specific Therapeutic Relationship Questionnaire (ITRQ) [58] | Therapeutic relationship. Measured by 8 items using 10-point Likert scales. | 8–80, higher scores indicate a better therapeutic relationship. | X Intervention group only | |||
Cost-effectiveness | Five-level EQ-5D (EQ-5D-5L) [59] | Health-related quality of life for economic evaluations. Measured by 5 items using 5-point Likert scales and 1 visual analog scale indicating an overall health score. | 5-point Likert scales, 1=no problems, 5=unable to/extreme problems. Visual analog scale, 0=worst health you can imagine, 100=the best health you can imagine. Dutch tariff [60]. | X | X | X |
iMTA Productivity Cost Questionnaire (iPCQ) [61] | Productivity losses. Measured by 12 items using open and yes/no questions and a 10-point Likert scale. | NA | X | X | X | |
iMTA Medical Consumption Questionnaire (iMCQ) [62] | Medical costs. Measured by 31 items using open and yes/no questions. Depending on the answers, not all items will be presented. | NA | X | X | X | |
ICEpop CAPability measure for Adults (ICECAP-A) [63] | Capability wellbeing. Measured by 5 items using 4-point Likert scales. | 5–20, higher scores indicate full capability. | X | X | X | |
Use of ICBT intervention | Contact with e-Coach | Content, frequency, and duration of contact with the e-coach | Log data e-Coach | X Intervention group only | ||
Evaluation of the intervention | Evaluation of the intervention. Measured by 23 items using several Likert scales and open questions. | NA | X Intervention group only |
Personal Profile Chart
Domain | Measure | Generic/disease-specific | Scale | Cut off points |
---|---|---|---|---|
Physical problems | ||||
Pain | Pain subscale, RAND Short Form-36 Health Status Inventory (RAND SF-36) [47] | Disease-specific | 20–60 | Green: ≥ 47.1; Orange: 47.0–35.1; Red: ≤ 35.0 |
Fatigue | Shortened Fatigue Questionnaire (SFQ) [49] | Disease-specific | 4–28 | Green: ≤ 17,9; Orange: 18.0–23.9; Red: ≥ 24.0 |
Itch | Itch subscale, Impact of Chronic Skin Disease on Daily Life (ISDL) [50] | Disease-specific | 3–16 | Green: ≤ 5.7; Orange: 5.8–8.9; Red: ≥ 9.0 |
Limitation in daily life | ||||
Limitations in daily activities | Role limitations due to physical problems subscale, RAND Short Form-36 Health Status Inventory (RAND SF-36) [47] | Disease-specific | 26–56 | Green: ≥ 33.1; Orange: 33.0–26.1; Red: ≤ 26.0 |
Limitations in social activities | Social functioning subscale, RAND Short Form-36 Health Status Inventory (RAND SF-36) [47] | Disease-specific | 12–57 | Green: ≥ 44.1; Orange: 44.0–31.1; Red: ≤ 31.0 |
Distress | ||||
Depressed mood | Generic | 0–27 | Green: ≤ 9; Orange: 10–19; Red: ≥ 20 | |
Anxiety | Generic | 0–21 | Green: ≤ 9; Orange: 10–14; Red: ≥ 15 |