Renal Dialysis
Conditions
Brief summary
Pilot-scale study to assess the effect of self-monitoring using the patientMpower electronic health journal (pMp app) \[+digital weighing scales & BP monitor\] on outcomes in ambulatory haemodialysis patients. Design: prospective, open-label, random order, sham-controlled, two-period crossover comparison of the pMp app \[+digital weighing scales & BP monitor\] compared with a sham application (without weighing scales or BP monitor). Duration: 10 weeks (usual care run-in for 2 weeks followed by 2 x 4 observation periods). Primary objective is to determine the frequency of use of the pMp app \[+digital weighing scales & BP monitor\] in patients randomized to that observation method. Additional objectives are to determine the effect of pMp app \[+digital weighing scales & BP monitor\] on proportion of haemodialysis sessions in which ultrafiltration rate is ≤ 10 mL/kg/h and in which interdialytic weight gain (IDWG) is ≤ 4% and effect of pMp on pre-dialysis weight and BP, medication adherence, compliance with daily recording (of fluid intake, weight, BP) and requirement for additional unscheduled dialysis. An additional objective is to assess the acceptability and utility of the pMp app in helping hemodialysis patients and their healthcare professional caregivers manage their condition (assessed from both patient and healthcare professional perspective).
Detailed description
Pilot-scale, prospective, open-label, randomized, two-period, cross-over intervention study. Each patient will be randomized to one of the two possible observation sequences: Sequence 1: run-in (2 weeks): usual care followed by period 1 (4 weeks): patientMpower application (+digital weighing scales & BP monitor) followed by period 2 (4 weeks): sham application OR Sequence 2: run-in (2 weeks): followed by period 1 (4 weeks) sham application followed by period 2 (4 weeks): patientMpower application (+digital weighing scales & BP monitor) The study will not make any other changes to the therapeutic interventions offered to the patients. Patients will follow their usual care and hemodialysis programme throughout the study. Proposed sample size is approximately 50 patients. Patients will be recruited through three haemodialysis facilities under the governance of Beaumont Hospital, a tertiary care centre for nephrology in Dublin, Ireland. The study observational intervention is an electronic health journal, the patientMpower application (with a supplied digital weighing scales and BP monitor). This has been developed specifically for patients undergoing hemodialysis. The app is an electronic application downloaded to the patient's mobile phone or tablet device. The app is designed to allow the patient to report various parameters relevant to hemodialysis and record these on a regular basis, ideally daily. The information recorded by the patients will be stored in a secure cloud system and will be available to the patient through their phone or mobile device at all times. No personal health data are stored on the phone or mobile device itself. Patient-reported measures (at a minimum) will include body weight (at least one reading /day), BP and compliance with relevant medication. Additional patient-reported measures which can be reported on the patientMpower app include body temperature, activity levels and symptoms. The control observation will be usual care with a sham electronic application (which will not allow recording of body weight, BP or other measurements). The objective of this pilot-scale cross-over open label randomized study is to assess the effect of self-monitoring using the patientMpower electronic health journal \[+digital weighing scales &BP monitor\] on outcomes in ambulatory hemodialysis patients.The primary objective will be to determine the frequency of use of the patientMpower app (+digital weighing scales & BP monitor).
Interventions
OTHERsham application
dummy application which does not allow recording of weight, blood pressure, medication adherence and symptoms
OTHERpatientMpower application
electronic health journal for patient to record weight, blood pressure, medication adherence and symptoms
Sponsors
Health Service Executive, Ireland
patientMpower Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective, open-label, sham-controlled, observational study. Usual care run-in period (2 weeks) followed by random order 2 x 4-week crossover periods. Comparison is active pMp app \[+ digital weighing scales + BP monitor\] for 4 weeks vs. sham application for 4 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Requires maintenance hemodialysis in an ambulatory care setting. * Aged at least 18 years. * Has daily unrestricted access to a suitable smart phone or tablet device at home. * Has an e-mail address. * Has home broadband and/or mobile data as part of their mobile phone service. * Demonstrates understanding of correct use of the patientMpower application, digital weighing scales, BP monitor and other study equipment. * Capable and willing to perform measurements (e.g. weight, BP) at home and record information on the patientMpower application on a daily basis. * Willing to give written informed consent.
Exclusion criteria
* Significant confusion or any concomitant medical condition, which would limit the ability of the patient to record symptoms or other parameters on an electronic health journal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Engagement With patientMpower App to Record Body Weight | 28 days | Actual number of days body weight reported by patient on patientMpower app |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Systolic Blood Pressure | 28 days | pre-dialysis supine systolic blood pressure |
| Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Diastolic Blood Pressure | 28 days | pre-dialysis supine diastolic blood pressure |
| Effect of patientMpower App [+Digital Scales & BP Monitor] on Ultrafiltration Rate (Proportion </= 10mL/kg/h) | 28 days | Proportion of hemodialysis sessions in which ultrafiltration rate is less than/equals 10mL/kg/h |
| Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Relative to Dry Weight) | 28 days | Average interdialytic weight gain as percentage of patient's dry weight |
| Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Absolute) | 28 days | Average interdialytic weight gain in kg |
| Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Proportion </= 4%) | 28 days | Proportion of hemodialysis sessions in which interdialytic weight gain is less than/equals 4% |
| Effect of patientMpower App [+Digital Scales & BP Monitor] on Predialysis Weight | 28 days | predialysis weight |
| Patient Engagement With patientMpower App to Record Medication Adherence | 28 days | actual number of days medication adherence reported by patient on patientMpower app |
| Patient Engagement With patientMpower App to Record Symptoms | 28 days | Actual number of days symptoms reported by patient on patientMpower application |
| Patient Engagement With patientMpower App to Record Fluid Intake | 28 days | Actual number of days fluid intake reported by patients on patientMpower application |
| Effect of patientMpower App [+Digital Scales & BP Monitor] on Requirement for Additional Unscheduled Hemodialysis. | 28 days | number of patients requiring additional unscheduled hemodialysis sessions |
| Patient Opinion on Utility and Acceptability of patientMpower Application | 28 days | Questionnaire-based assessment: 7 questions. \[pMp = patientMpower intervention\] 1. using pMp helped me to take correct dose of my medicines every day 2. using pMp gave me more confidence/greater sense of control in managing my health 3. my preference for using pMp 4. my difficulty rating in using pMp 5. effect of using pMp on my well-being and daily life 6. do I want to continue using pMp after study end 7. did I like using pMp Possible responses Q1, Q2: strongly agree/agree/disagree/strongly disagree; Q3: yes/no preference/no; Q4: very easy/easy/difficult/very difficult; Q5: positive/negative; Q6: yes/no; Q7: 10-point linear scale: 1 (did not like at all) to 10 (liked a lot) |
| Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Collapsibility | 28 days | number of patients with at least 50% collapsibility |
| Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Longitudinal Diameter | 28 days | longitudinal diameter |
| Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Transverse Diameter | 28 days | transverse diameter |
| Patient Engagement With patientMpower App to Record Blood Pressure. | 28 days | actual number of days blood pressure reported by patient on patientMpower app |
Countries
Ireland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Patients All patients who started patientMpower observation period | 43 |
| Total | 43 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants |
| Age, Continuous | 51.42 years STANDARD_DEVIATION 13.98 |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized black | 3 Participants |
| Race/Ethnicity, Customized white | 39 Participants |
| Region of Enrollment Ireland | 43 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 28 Participants |
| time since first-ever hemodialysis | 3.44 years STANDARD_DEVIATION 3.71 |
| vascular access modality arteriovenous fistula | 18 Participants |
| vascular access modality permcath | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 43 |
| other Total, other adverse events | 0 / 43 | 1 / 43 |
| serious Total, serious adverse events | 1 / 43 | 2 / 43 |
Outcome results
Primary
Patient Engagement With patientMpower App to Record Body Weight
Actual number of days body weight reported by patient on patientMpower app
Time frame: 28 days
Population: All patients who started patientMpower observation period and who recorded weight at least once
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Patient Engagement With patientMpower App to Record Body Weight | 24 days | Standard Deviation 6 |
Secondary
Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Absolute)
Average interdialytic weight gain in kg
Time frame: 28 days
Population: Average of interdialytic weight gain per patient for all haemodialysis sessions in each observation period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Absolute) | 2.29 kg | Standard Deviation 0.74 |
| patientMpower | Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Absolute) | 2.22 kg | Standard Deviation 0.71 |
Secondary
Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Proportion </= 4%)
Proportion of hemodialysis sessions in which interdialytic weight gain is less than/equals 4%
Time frame: 28 days
Population: Average of the proportion of hemodialysis sessions per patient in which interdialytic weight gain is less than/equals 4% in observation period
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Patients | Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Proportion </= 4%) | 0.83 proportion of sessions |
| patientMpower | Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Proportion </= 4%) | 0.83 proportion of sessions |
Secondary
Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Relative to Dry Weight)
Average interdialytic weight gain as percentage of patient's dry weight
Time frame: 28 days
Population: Average of interdialytic weight gain per patient for all haemodialysis sessions in each observation period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Relative to Dry Weight) | 2.76 % of dry weight | Standard Deviation 0.96 |
| patientMpower | Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Relative to Dry Weight) | 2.68 % of dry weight | Standard Deviation 0.92 |
Secondary
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Diastolic Blood Pressure
pre-dialysis supine diastolic blood pressure
Time frame: 28 days
Population: average of the clinic-observed pre-dialysis supine diastolic blood pressures per patient in the observation period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Diastolic Blood Pressure | 75.2 mmHg | Standard Deviation 14.8 |
| patientMpower | Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Diastolic Blood Pressure | 74.5 mmHg | Standard Deviation 15.2 |
Secondary
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Collapsibility
number of patients with at least 50% collapsibility
Time frame: 28 days
Population: All patients who had measurement of inferior vena cava diameter assessed pre-dialysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Patients | Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Collapsibility | 7 Participants |
| patientMpower | Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Collapsibility | 6 Participants |
Secondary
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Longitudinal Diameter
longitudinal diameter
Time frame: 28 days
Population: All patients who had measurement of inferior vena cava diameter assessed pre-dialysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Longitudinal Diameter | 1.7 cm | Standard Deviation 0.5 |
| patientMpower | Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Longitudinal Diameter | 1.8 cm | Standard Deviation 0.5 |
Secondary
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Transverse Diameter
transverse diameter
Time frame: 28 days
Population: All patients who had measurement of inferior vena cava diameter assessed pre-dialysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Transverse Diameter | 1.5 cm | Standard Deviation 0.6 |
| patientMpower | Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Transverse Diameter | 1.5 cm | Standard Deviation 0.6 |
Secondary
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Systolic Blood Pressure
pre-dialysis supine systolic blood pressure
Time frame: 28 days
Population: average of the clinic-observed pre-dialysis supine systolic blood pressures per patient in the observation period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Systolic Blood Pressure | 146.6 mmHg | Standard Deviation 18.4 |
| patientMpower | Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Systolic Blood Pressure | 146.3 mmHg | Standard Deviation 19.6 |
Secondary
Effect of patientMpower App [+Digital Scales & BP Monitor] on Predialysis Weight
predialysis weight
Time frame: 28 days
Population: average of the pre-dialysis clinic observed weights per patient in the observation period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Effect of patientMpower App [+Digital Scales & BP Monitor] on Predialysis Weight | 89.15 kg | Standard Deviation 23.3 |
| patientMpower | Effect of patientMpower App [+Digital Scales & BP Monitor] on Predialysis Weight | 89.27 kg | Standard Deviation 23.34 |
Secondary
Effect of patientMpower App [+Digital Scales & BP Monitor] on Requirement for Additional Unscheduled Hemodialysis.
number of patients requiring additional unscheduled hemodialysis sessions
Time frame: 28 days
Population: All patients who started the sham or patientMpower observation period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Patients | Effect of patientMpower App [+Digital Scales & BP Monitor] on Requirement for Additional Unscheduled Hemodialysis. | 2 Participants |
| patientMpower | Effect of patientMpower App [+Digital Scales & BP Monitor] on Requirement for Additional Unscheduled Hemodialysis. | 2 Participants |
Secondary
Effect of patientMpower App [+Digital Scales & BP Monitor] on Ultrafiltration Rate (Proportion </= 10mL/kg/h)
Proportion of hemodialysis sessions in which ultrafiltration rate is less than/equals 10mL/kg/h
Time frame: 28 days
Population: Average of the proportion of hemodialysis sessions per patient in which ultrafiltration rate is less than/equals 10 mL/kg/h in observation period
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Patients | Effect of patientMpower App [+Digital Scales & BP Monitor] on Ultrafiltration Rate (Proportion </= 10mL/kg/h) | 0.83 proportion of sessions |
| patientMpower | Effect of patientMpower App [+Digital Scales & BP Monitor] on Ultrafiltration Rate (Proportion </= 10mL/kg/h) | 0.83 proportion of sessions |
Secondary
Patient Engagement With patientMpower App to Record Blood Pressure.
actual number of days blood pressure reported by patient on patientMpower app
Time frame: 28 days
Population: All patients who started patientMpower observation period and who recorded blood pressure at least once
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Patient Engagement With patientMpower App to Record Blood Pressure. | 18 days | Standard Deviation 8 |
Secondary
Patient Engagement With patientMpower App to Record Fluid Intake
Actual number of days fluid intake reported by patients on patientMpower application
Time frame: 28 days
Population: All patients who started patientMpower observation period and who recorded fluid intake at least once on patientMpower app
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Patient Engagement With patientMpower App to Record Fluid Intake | 13 days | Standard Deviation 8 |
Secondary
Patient Engagement With patientMpower App to Record Medication Adherence
actual number of days medication adherence reported by patient on patientMpower app
Time frame: 28 days
Population: All patients who started patientMpower observation period and recorded medicines adherence at least once
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Patients | Patient Engagement With patientMpower App to Record Medication Adherence | 18 days |
Secondary
Patient Engagement With patientMpower App to Record Symptoms
Actual number of days symptoms reported by patient on patientMpower application
Time frame: 28 days
Population: All patients who started patientMpower observation period and who recorded symptoms at least once on patientMpower app
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Patient Engagement With patientMpower App to Record Symptoms | 13 days | Standard Deviation 8 |
Secondary
Patient Opinion on Utility and Acceptability of patientMpower Application
Questionnaire-based assessment: 7 questions. \[pMp = patientMpower intervention\] 1. using pMp helped me to take correct dose of my medicines every day 2. using pMp gave me more confidence/greater sense of control in managing my health 3. my preference for using pMp 4. my difficulty rating in using pMp 5. effect of using pMp on my well-being and daily life 6. do I want to continue using pMp after study end 7. did I like using pMp Possible responses Q1, Q2: strongly agree/agree/disagree/strongly disagree; Q3: yes/no preference/no; Q4: very easy/easy/difficult/very difficult; Q5: positive/negative; Q6: yes/no; Q7: 10-point linear scale: 1 (did not like at all) to 10 (liked a lot)
Time frame: 28 days
Population: All patients who started the patientMpower observation period and provided a response to the questionnaire
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | Patient Opinion on Utility and Acceptability of patientMpower Application | liked using pMp: score at least 8/10 | 15 participants |
| All Patients | Patient Opinion on Utility and Acceptability of patientMpower Application | positive effect pMp on well-being/daily life = yes | 19 participants |
| All Patients | Patient Opinion on Utility and Acceptability of patientMpower Application | pMp helped me take my correct medicines/day | 12 participants |
| All Patients | Patient Opinion on Utility and Acceptability of patientMpower Application | pMp gave me greater confidence/control | 19 participants |
| All Patients | Patient Opinion on Utility and Acceptability of patientMpower Application | preferred using pMp = yes | 14 participants |
| All Patients | Patient Opinion on Utility and Acceptability of patientMpower Application | pMp easy or very easy to use | 21 participants |
| All Patients | Patient Opinion on Utility and Acceptability of patientMpower Application | want to continue using pMp after study end = yes | 18 participants |