Table 1. Characteristics of the trials included in the review.
| Reference | Trial design / Population (Type of adherence) / Interventionist (theoretical models of behaviour if any) | Total No (Intervention/ Control) N/ Mean age (years) | Intervention | Domain and (category) of adherence intervention / Duration of intervention (d = day, wk = weeks, m = months) | Outcome relevant to treatment adherence | Total F/U in m(months) / Study result / Benefit sust-ained beyond intervention |
|---|---|---|---|---|---|---|
| Ashurst I de Brito et al (2003) [24] | Parallel group / HD (Diet + Medication) /Dietitian | 58 (29/29) / 53.6 | One-on-one education session by Dietitian based on "A Patient's guide to keeping healthy: Managing your phosphate", manual developed by Genzyme Pharmaceuticals. Also provided Medication chart to fill in self-administered doses of medications and blood results to increase patient engagement | Patient related interventions (Educational/cognitive) / 1 d | Change in levels of phosphate, calcium, calcium x phosphate product | 6 m/ Partially positive |
| Baraz S et al (2010) [13] | Parallel group / HD (Diet+ Fluid+ Medication) / Nurses | 63 (31/32) / 34.9 | Oral education lasting 30 minutes each over two group sessions and a booklet "A patient's guide to controlling dietary regimen" vs Video education lasting 30 minutes during haemodialysis session with similar content including diet, importance of compliance etc | Patient related interventions (Educational/ cognitive) / 1 d | Change in IDWG. Change in levels of phosphate, calcium, potassium | 4 m / Partially positive |
| Brantley P J et al (1990) [25] | Cluster randomized / HD (Vascular access cleansing) / Multiple staff | 56 (14/14#/ 14#/14) / 56.6 | Educational video of vascular access cleansing lasting 20minutes for 3 sessions over one week (Educational) / provision of visual cues to help cleaning, such as information board and monetary incentives in the form of raffles (Behavioural)/, the above two together (Educational & Behavioural) / attention control included video about vascular access without information on cleaning ((Control) | Patient related interventions (Educational/ cognitive & Counselling / behavioural) / 1 wk | Vascular access cleansing compliance | 12 m / Positive at 1 month / Benefit wanes @ 12 m F/U |
| Chen W et al (2006) [26] | Parallel group / PD (Diet) / Dietitian | 70 (35/35) / 55.3 | Food menu suggestion and individualized education on food exchange based on patient preference | Patient related interventions (Educational/cognitive) / 1 d | Protein intake compliance computed from 3 days self-reported diet, Change in levels of phosphate, albumin | 1 m / Partially positive |
| Cho M K et al (2013) [12] | Parallel group / HD (Diet + Fluid + Medication) / Nurses (King's theory of goal attainment) | 43 (21/22) / 60.4 | Health contract intervention lasting 30–60 minutes per week for 4 weeks which included formal introduction to the program, mutual goal setting, contracting and re-contracting to support selfcare behaviour reinforced through praise, encouragement and support | Patient related interventions (Counselling / behavioural) / 4 wk | Inventory (develop-ed by Song et al) to assess self-care behaviour including fluid intake, diet, medications, exe-rcise, physical man-agement and social adjustment, Change in IDWG, Change in levels of phosphate, potassium | 1 m / Partially positive/ NA |
| Cukor D et al (2014) [10] | Crossover randomized / HD (Fluid) / Psychologist | 59 (33/26) | Cognitive behavioural therapy (CBT) delivered chairside by psychologist over 60 minutes per for 3 months. Included psycho-education emphasising difference between depression and medical illness, components of adherence targeting dialysis compliance, adapting behavioural activation and identifying ESRD specific cognitive distortions | Patient related interventions (Educational/ cognitive & Counselling / behavioural) / 3 m | Change in IDWG | 6 m / Partially positive / Positive @ 3 m/ Benefit wanes @ 3 m F/U |
| Cummings K M et al (1981) [27] | Parallel group / HD (Diet + Fluid) / Nurses (Health belief model) | 96 (24/19#/ 28#/25) / 54.8 | Three Intervention groups. 1. Behavioural contracting (included Identifying behaviour needing change, set time table for change, writing formal agreement and recording of progress) with reward schedule in the form of lottery tickets 2. Above intervention with family member/friend in addition to patient 3. Weekly telephone contact by nurse with structured content including identification of non-adherence, highlighting information on negative consequences of non-adherence and verbal support for maintaining adherence once a week for 6 weeks with hope of modifying health beliefs | Patient related interventions (Counselling / behavioural) / 6 wk | Change in IDWG. Change in levels of potassium, Health beliefs about diet and fluid | 4.5 m / Partially positive / Positive @ 6 wk/ No benefit @ 3m F/U |
| de Araujo L P et al (2010) [28] | Parallel group / HD (Diet + Medication) / Multiple staff | 33 (16/17) / 52.5 | Six educational sessions lasting 30 minutes each about importance of avoiding high phosphate diet, correct use of phosphate binders, importance of blood results of calcium, phosphate, calcium, phosphate product, PTH and manifestations of bone disease in a course over 2 weeks | Patient related interventions (Educational/cognitive) / 2 wk | Change in levels of phosphate, calcium, calcium x phosphate product, PTH, Knowledge about diet and binders | 3 m / Negative (only one outcome assessment @ 3 m) |
| Ford J C et al (2004) [29] | Parallel group / HD (Diet + Medication) / Dietitian | 70 (35/35) | 20–30 minutes of additional dietary education every month by dietician in addition to standard education, using tools including posters, handouts, puzzles, individual phosphorous tracking instruments highlighting dietary phosphate content, importance of diet, drugs and dialysis in phosphate control | Patient related interventions (Educational/cognitive) / 6 m | Change in levels of phosphate, calcium, calcium x phosphate product, PTH, Knowledge about diet and binders | 6 m / Partially positive / NA |
| Forni Ogna V et al (2013) [8] | Parallel group / HD (Medication) / Multiple staff | 50 (24/26) / 60.2 | Integrated care approach (MEMS monitoring, motivational interviewing start 2m later with MEMS graphical report, identify barriers to non-adherence and strategies to address them, discussion about adherence) | Patient related interventions (Educational/cognitive & Counselling / behavioural) / 6 m | Change in levels of iPTH level, MEMS adherence (cinacalcet taking) and dose of Cinacalcet | 9 m / Positive @ 6 m/ Benefit wanes @ 3 m post intervention |
| Griva K et al (2018) [30] | Cluster randomized / HD (Diet + Fluid + Med + Dialysis) / Multiple staff (Social cognitive theory) | 235 (101/134) / 53.5 | Three core and one booster group education sessions, totalling 8 hours, targeting self-management behaviour related to fluid intake, diet and medications and telephone follow-up between core & booster sessions | Patient related interventions (Educational/ cognitive & Counselling / behavioural) / 3 m (including core & booster sessions & phone F/U) | Change in IDWG. Change in levels of phosphate, potassium. Renal adherence behav-iour questionnaire (Fluid, potassium, phosphate, sodium, adherence in times of difficulty, self-care) | 9 m / Positive @ 3m/ Benefit wanes @ 9 m post intervention |
| Haq N et al (2014) [31] | Parallel group / HD (Medication) / Dialysis staff | 23 (12/11) / 52.5 | Directly observed therapy in front of haemodialysis nurses administering cinacalcet 3 times a week during dialysis | Health system related interventions (Supervised therapy) / 4 m | Change in levels of phosphate, calcium, PTH | 4 m / Negative / NA |
| Hare J et al (2014) [32] | Parallel group / PD (Fluid) / Psychologist (Health belief model) | 15 (8/7) / 60.1 | Group format CBT for groups of 6–8 patients at a time in 1-hour sessions per week for 4 weeks. The program was called Liquid intake program (LIP) which was adapted (and renamed) from the Glasgow university liquid program (GULP) used in by Sharp et al 2005. The structured program included Introduction, goal setting and environment change, thought, emotions and behaviour as well as social support and program review | Patient related interventions (Educational/ cognitive & Counselling /behavioural) / 4 wk | Fluid adherence assessed by weight reduction >2Kg, BP, Psychological markers (psychological well-being, quality of life, health beliefs) | 2.5 m / Negative post-intervention & 6 wk F/U |
| Hou Y M et al (2010) [33] | Parallel group / HD (Fluid) / Psychologist (ABC theory) | 92 (48/44) / 44.6 | Rational emotive therapy establishing a good patient-caregiver relationship with a structured program with introduction providing basic knowledge and psychological health, description of rational emotive therapy and ABC theory, procedure of rational emotive therapy in three phases including psycho-diagnosis, comprehension and application | Patient related interventions (Psychological / affective) / 3 m | Change in IDWG, BP, Ultrafiltration volume | 3 m /Positive / NA |
| Howren M B et al (2016) [34] | Cluster randomized / HD (Fluid) / Psychologist (Self-regulation theory) | 119 (61/58) /57.1 | Highly structured behavioural self-regulation intervention sessi-ons administered by psychologists to group of 3–8 participants lasting one hour weekly for 7 weeks, including illustration of behavioural principles, group discussions and homework assign-ments specific to fluid adherence comprising of self-regulation techniques, goal setting, self-administered reinforcement strategies, stimulus control, evaluation of group experience | Patient related interventions (Counselling /behavioural & Psychological / affective) / 7 wk | Change in IDWG | 8 m / Positive / Benefit present @ 6 m F/U |
| Karavetian M et al (2013) [7] | Cluster randomized / HD (Diet + Medication) / Dietitian (Self efficacy theory) | 122 (41/41 #/40) / 57.0 | Self-management dietary counselling and interactive games for 20 minutes per week for 8 weeks. Also included discussion for 10 minutes every month about bone mineral disease related parameters and relevant nutritional counselling | Patient related interventions (Educational/ cognitive & Counselling / behavioural) / 8wk | Change in levels of phosphate, calcium, calcium x phosphate product. Knowledge. Dietary non-adherence by questionnaire | 2 m / Positive / NA |
| Karavetian M et al (2015) [35] | Cluster randomized / HD (Diet) / Dietitian (Trans-theoretical model) | 394 (88/ 201# /96)/ 58.8 | Individualized intensive trans-theoretical stage-based nutrition education twice weekly for six months by an academic dietitian. A partial intervention group provided a second control group | Patient related interventions (Educational/cognitive) / 6 m | Change in phosphate levels. Phosphate intake. Knowledge about dietary phosphate | 12 m / Positive at 6 month / Benefit wanes @ 6 m F/U |
| Kauric-Klein Z et al (2012) [9] | Cluster randomized / HD (Diet + Fluid + Medication + Dialysis) / Nurses | 118 (59/59) / 59.7 | Two blood pressure education sessions, self-monitoring of BP for 12 weeks checking it twice a day with logs, goal setting for BP levels, Fluid gains and Salt intake and haemodialysis compliance with reinforcement sessions lasting 10–15 minutes per week for twelve weeks with supportive nursing intervention | Patient related interventions (Educational/ cognitive & Counselling / behavioural) / 12wk | BP self-care beh-aviour, (IDWG, Salt intake, BP med adherence–self-re- ported), BP, Dialysis adherence (missed HD sessions) | 4 m /Partially positive @ 3m / Benefit persists @ 1 m F/U |
| Lou LM et al (2012) [36] | Cluster randomized / HD (Diet) / Dietitian | 80 (41/39) / 62.3 | Register with dietitian who provides detailed menu suggestions adapted to patients plus targeted dietary education concerning phosphorous intake lasting 30minutes every by dietitian | Patient related interventions (Educational/cognitive) / 6 m | Change in levels of phosphate. Per-centage of patients achieving phos-phate goal. PTH. Nutritional measur-es—BMI/ albumin/ fat free mass | 6 m / Positive / NA |
| Molaison E F et al (2003) [37] | Cluster randomized / HD (Fluid) / Multiple staff (Trans-theoretical model) | 316 (216/100) / 53.8 | Dietitian intervention using stages of change in the trans-theoretical model to improve fluid intake. First 6 weeks phase of Pre-action including precontemplation and contemplation, second 6week phase of Action including preparation, action and maintenance. Communication to patients maintained through bulletin boards, handouts and feedback. Constructs included consciousness raising, self-evaluation, counter-conditioning, stimulus control, self-efficacy etc | Patient related interventions (Educational/ cognitive & Counselling / behavioural) / 12wk | Change in IDWG, Stage of change in fluid adherence, Knowledge | 3 m / Negative /Knowledge improved / NA |
| Morey B et al (2008) [38] | Parallel group / HD (Diet + Medication) / Dietitian | 67 (34/33) / 57.7 | Intensive dietary counselling every month for 6months about phosphate in diet and phosphate binder use using motivational counselling, behaviour modification therapy, reminders, reinforcement, supportive care as well as written and verbal education | Patient related interventions (Educational/ cognitive & Counselling /behavioural) / 6 m | Change in levels of phosphate, calcium, calcium x phosph-ate product, PTH, albumin, Nutritional measures: hand grip, mid-arm circumference | 12 m / Negative after intervention @ 6 m & 6 m F/U |
| Neumann C L et al (2013) [11] | Parallel group / HD (Fluid) / Multiple staff | 120 (60/60) / 66.1 | Body weight telemetry with phone calls triggered by thresholds detected during monitoring with >1.5kg/d weight gain mandating phone call, 0.75–1.5Kg/d weight gain prompting individualized decision making based on patient profile | Health system related interventions (Monitoring / engagement) / 3 m | Change in IDWG, BP | 3 m / Partially positive / NA |
| Pasyar N et al (2015) [39] | Parallel group / HD (Diet + Fluid + Medication) / Professional relaxation therapist | 86 (43/43) | Benson relaxation technique of progressive muscle relaxation with breathing awareness for 20 minutes twice a day for 8 weeks | Patient related interventions (Psychological / affective) / 8 wk | Change in IDWG, Change in levels of phosphate, potassium, chemistry | 2 m / Partially positive / NA |
| Reese P P et al (2015) [6] | Parallel group / HD (Diet + Medication) / Dietitian | 36 (12/12#/ 12) / 53.0 | Intervention group 1 received financial incentives including envelopes with cash and lottery for achieving goal range and those with above goal range received envelopes with messages designed to avoid regret aversion. Intervention group 2 received coaching for 45–60 minutes 3 times a week by Dietitian trained in motivational interviewing, structured as per Precaution Adoption process model in addition to discussing phosphate in diet, phosphate binders and identified personalized goals to achieve dietary and medication adherence | Patient related interventions (Educational/ cognitive & Counselling / behavioural) / 10 wk | Change in level of phosphate, Medication adherence by questionnaire | 2.5 m / Negative / NA |
| Sehgal A R et al (2002) [40] | Cluster randomized / HD (Dialysis) / Multiple staff | 169 (85/84) / 54.5 | Identify barriers with respect to low prescription, catheter use for access and shortened treatment time & individually address by liaising with randomized nephrologists and engaging with patients to resolve barriers | Health system related interventions / Patient related interventions (Monitoring / engage-ment & Educational / cognitive) / 6m | Change in Kt/V, Proportion of patients achieving goal Kt/V | 6 m / Positive / NA |
| Sharp J et al (2005) [41] | Cluster randomized / HD (Fluid) / Psychologist (Health belief model) | 56 (29/27) / 54.3 | Glasgow University liquid intake program (GULP) administered by Psychologist structured as small group (3–8 subjects) interactive sessions lasting 1 hour per week for 4 weeks, with educational component providing information about importance of fluid restriction, behavioural component of teaching self-monitoring skills, goal setting and self-regulation as well as cognitive components of encouraging to identify association between thoughts, emotions and behaviours. Patients were advised to complete thought records | Patient related interventions (Educational/ cognitive & Counselling / behavioural) / 4 wk | Change in IDWG, Health-belief Questionnaire adapted from Friend et al regarding fluid | 3.5 m / Negative @ 4 weeks / Benefit within group @ 10 wk F/U |
| Shi Y X et al (2013) [42] | Parallel group / HD (Diet + Medication) / Nurses | 80 (40/40) / 53.3 | Nurse led education lasting 30 minutes two or three times a week for six months, written educational material and monthly group educational sessions for six months | Patient related interventions (Educational/cognitive) / 6 m | Change in levels of phosphate, calcium, calcium x phosphat- e product, albumin, Knowledge | 6 m / Positive / NA |
| Skoutakis V A et al (1978) [43] | Parallel group / HD (Diet + Medication) / Pharmacist | 24 (12/12) / 47.0 | Pharmacist review two to three times a week for four months supplying educational materials, consultation regarding health, benefits of compliance with diet and medicines and written reminders about taking oral medications. Clarification of physician instructions and drug titration advice was also provided | Patient related interventions (Educational/ cognitive) / 4 m | Knowledge, Weighted drug dose compliance (differ-ent drug classes). Weighted biochem-ical profile (potassium, urea, Weight gain, BP) | 8 m / Positive / Benefit wanes @ 4 m F/U |
| Sullivan C et al (2009) [44] | Parallel group / Cluster randomized / HD (Diet) / Dietitian | 279 (145/134) / 53.0 | Education about phosphorous content of food additives, provision of magnifier lens to enable food label readings, printed information containing fast food info and better choices. Telephone contact next month to reinforce advice | Patient related interventions (Educational/ cognitive) / 2 m (including telephone F/U) | Change in level of phosphate, Nutritional knowledge, Reading labels | 3 m / Partially positive / NA |
| Tanner JL et al (1998) [45] | Parallel group / HD (Diet + Fluid + Medication) / Dietitian (Health belief model / Self efficacy theory) | 40 (30/10) / 50.2 | Monthly progress report with IDWG (<3Kg weekdays, <4Kg weekends), and phosphorous (<5.9mg/dl) goals with sticker incentives for acceptable results and monthly written behavioural contracts to assist in one or more goals. Results reviewed monthly and recontracted each month, increasing complexity over time | Patient related interventions (Counselling / behavioural) / 6 m | Change in level of phosphate, Number of dialysis sessions with acceptable IDWG (>8 of 12 HD sessions), Knowle-dge, Self-efficacy | 6m / Negative (Knowledge was better @ 6 m) / NA |
| Tsay S L et al (2003) [46] | Parallel group / HD (Fluid) / Nurses (Self efficacy theory) | 62 (31/31) / 57.7 | Structured self-efficacy training comprising of a total of 12 sessions of one hour each, individualized education about renal failure, haemodialysis, medications, fluid restrictions performance mastery, realistic gaol setting, verbal persuasion with encouragement and decreased arousal through physical relaxation listening to audiotapes. Patients also were advised to maintain food and fluid records | Patient related interventions (Educational /cognitive & Counselling /behavioural) / 1 m | Change in IDWG | 6m / Positive / Benefits present @ 6m |
| Welch J L et al (2013) [47] | Parallel group / HD (Fluid + Overall) / Nurses (Social cognitive theory) | 44 (24/20) / 50.3 | Dietary intake monitoring application (DIMA) a mobile application developed using nutrition database and universal product code (UPC) database, provides individualized ongoing information to assist patients with dietary and fluid self-monitoring | Patient related interventions (Educational/cognitive & Counselling /behavioural) / 6 wk | Change in IDWG, Self-efficacy measures by modified Cardiac diet self-efficacy (SE) instrument & Fluid SE scale | 14 wk / Negative / NA |
| Wileman V et al (2016) [48] | Cluster randomized / HD (Fluid) / Psychologist (self-affirmation theory) | 89 (49/40) / 60.7 | Re-affirmation act before receiving health information about fluid overload and risks at baseline and briefer re-affirmation act before health information at 1,3 and 6 months. The act required participants to recall past act of kindness. The health information was followed by questionnaire exploring perception of risk, intention and self-efficacy to control their fluid intake. | Patient related interventions (Psychological / affective) / 6m (including F/U sessions @ 3m & 6m) | Change in IDWG. Self-reported measure of fluid intake (1–5 scale), Self-efficacy | 12 m / Partially positive / Benefits persisted @ 12 m |
| Wileman V et al (2014) [49] | Cluster randomized / HD (Diet + Medication) / Psychologist (self-affirmation theory) | 112 (57/55) / 60.5 | Re-affirmation act before receiving health information about phosphate control and risks at baseline and briefer re-affirm-ation act before health information at 1,3 and 6 months. The act required participants to recall past act of kindness. The health information was followed by questionnaire exploring perception of risk, intention and self-efficacy to control their phosphate. | Patient related interventions (Psychological / affective) / 1 d | Change in phosphate levels, Self-reported measures, Self-efficacy | 12 m / Partially positive / Benefits persisted @ 12 m |
| Wong F K Y et al (2010) [50] | Parallel group / PD (Diet + Fluid+ Medication + Dialysis) / Nurses | 98 (49/49) / 62.4 | Nurse led disease management program for 6 wk based on the 4-Cs model comprising of Comprehensiveness, Collaboration, Coordination and Continuity-run by Renal & General nurses. Content of the program included assessment using the Omaha system modified for renal patients, arts and skills of telephone nursing, setting mutual goals and health coaching, use of disease management protocols and concept of disease management process and outcomes | Health system related interventions (Monitoring / engagement) / 6 wk | Self-reported adherence using a modified version of dialysis, diet and fluid questionnaire (DDFQ) | 3 m / Partially positive / Some benefits persist @ 3m |
| Yokum D et al (20018) [51] | Parallel group / HD (Diet + Medications) / Multiple staff | 34 (17/17) / 49.4 | Pharmacist & Dietitian adjust phosphate binders as per protocol in addition to monthly reviews by Pharmacist and Dietitian to provide education and reinforcement | Health system related interventions / Patient related interventions (Monitoring / engagement & Educational / cognitive) | Change in phosphate, calcium, calcium x phosphate product, PTH | 4 m / Partially positive / NA |
Abbreviations or symbols used in the table: BP = blood pressure, CBT = cognitive behavioural therapy, ‘d’ = day, F/U = follow-up, HD = haemodialysis, IDWG = inter-dialytic weight gain, ‘m’ = months, MEMS = medication event monitoring system, NA = not applicable, PD = peritoneal dialysis, PTH parathyroid hormone, ‘wk’ = weeks,
# indicates the number of patients in alternative intervention group. Additional details about the study characteristics and outcome data are provided in S2 Table.