The purpose of this 2-group, randomized, controlled trial is to evaluate the refined SystemCHANGE™ against attention control patient education in CKD patients taking RAAS medications.
In this study, the investigators will test a refined SystemCHANGE™ in patients taking RAAS inhibiting medications. Participants will be recruited from two sources: 1) the largest and most comprehensive health care system in the state and 2) one of the largest essential health care systems in the country. Data are collected at baseline, 8 weeks (immediately post-intervention), and 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
150
Participants randomized to the refined SystemCHANGE™ intervention will receive 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and weekly feedback MMS message reports delivered to mobile phones.
Participants randomized to attention control will receive nurse-led kidney disease self-care education based on materials developed by The National Institute of Diabetes and Digestive and Kidney Diseases and The National Kidney Foundation. Similar to the intervention, participants will receive one virtual visit from the nurse-interventionist and 6 phone calls (weeks 2, 3, 4, 5, 6 and 7) and weekly educational MMS messages delivered by mobile phone.
Indiana University School of Nursing
Indianapolis, Indiana, United States
Percentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence)
Monitored by electronic MEMS caps (AARDEX Group, Belgium) which record the date and time the cap is removed as a proxy for medication being taken.
Time frame: 8 Weeks
Percentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence)
Monitored by electronic MEMS caps (AARDEX Group, Belgium) which record the date and time the cap is removed as a proxy for medication being taken.
Time frame: 12 Weeks
Number of Participants Qualitatively Analyzed From the Investigator-designed 10-item Acceptability Questionnaire Which Assesses Nurse-intervention Interaction and Mobile Technology Acceptability.
Response options ranging from 5 (strongly agree) to 1 (strongly disagree). There is no total score. Depending on question "strongly agree" or "strongly disagree" may be related to better acceptability of the intervention. Answers on this survey guided development of individual interview questions to be qualitatively evaluated. The items on the Acceptability Scale, for example, had response options ranging from 5 (strongly agree) to 1 (strongly disagree). If a person indicated strong agreement with the item "Getting messages on the mobile phone helps support my health behaviors," we would develop interview questions to read "You indicated on your survey that getting messages on your phone supported your health behaviors. Tell me what behaviors the messages supported? Give me an example one of these behaviors."
Time frame: 12 weeks
Outcome Expectancy Questionnaire
This questionnaire measures the affective or emotional aspect of the client's expectations regarding improvement. It asks how much the client expects to improve as a result of the intervention. This is related to the client's emotional responses and affective processes, capturing their hopeful anticipation or optimism about the intervention outcomes. Higher scores indicate greater belief that the program will be beneficial. For outcome expectancy, the three questions will indicate how much they 1) think and 2) feel the program will help improve medication-taking using a 0 to 10 scale where 0 is no change and 10 is complete improvement, and how much they 3) feel it will reduce missing or taking medications late using 0 (the intervention won't help to reduce missed doses) to 10 (I won't miss any doses). Responses to the three questions are standardized and summed to create a total subscale score (range 0-30).
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Time frame: 8 Weeks
Outcome Expectancy Questionnaire
This questionnaire measures the affective or emotional aspect of the client's expectations regarding improvement. It asks how much the client expects to improve as a result of the intervention. This is related to the client's emotional responses and affective processes, capturing their hopeful anticipation or optimism about the intervention outcomes. Higher scores indicate greater belief that the program will be beneficial. For outcome expectancy, the three questions will indicate how much they 1) think and 2) feel the program will help improve medication-taking using a 0 to 10 scale where 0 is no change and 10 is complete improvement, and how much they 3) feel it will reduce missing or taking medications late using 0 (the intervention won't help to reduce missed doses) to 10 (I won't miss any doses). Responses to the three questions are standardized and summed to create a total subscale score (range 0-30).
Time frame: 12 Weeks
Credibility Questionnaire
This questionnaire measures the logical and cognitive evaluation of the treatment. It assesses how credible or believable the treatment seems to the client. Questions on this scale typically ask about the perceived scientific legitimacy, logic, and reliability of the treatment. It taps into the client's rational thought processes and their cognitive appraisal of the treatment's potential effectiveness. Scores on the 3 questions indicate belief the program is credible. For treatment credibility items, participants indicate how 1) logical the program is and 2) how successfully they think it will help prevent missing or taking medications late, and 3) confidence recommending it to a friend all on a 0 to 10 scale and where 0 not logical, not credible, and participant is not confident in recommending to a friend to 10 logical, credible, and would recommend to a friend. Responses are standardized and summed to create a total subscale score on the three questions for a range of 0-30.
Time frame: 8 weeks
Credibility Questionnaire
This questionnaire measures the logical and cognitive evaluation of the treatment. It assesses how credible or believable the treatment seems to the client. Questions on this scale typically ask about the perceived scientific legitimacy, logic, and reliability of the treatment. It taps into the client's rational thought processes and their cognitive appraisal of the treatment's potential effectiveness. Scores on the 3 questions indicate belief the program is credible. For treatment credibility items, participants indicate how 1) logical the program is and 2) how successfully they think it will help prevent missing or taking medications late, and 3) confidence recommending it to a friend all on a 0 to 10 scale and where 0 not logical, not credible, and participant is not confident in recommending to a friend to 10 logical, credible, and would recommend to a friend. Responses are standardized and summed to create a total subscale score on the three questions for a range of 0-30.
Time frame: 12 Weeks
Personal Systems Thinking
20-item Systems Thinking Scale (adapted for patients) was totaled from a 5-point scale (Never, Seldom, Some of the time, Often, Most of the time). Range 20 (personal motivation) -100 (system level thinking). This survey assesses participants view of behavior from a personal (motivation) level to a system (environmental) level. This scale evaluates intervention to improve systems thinking away from a personal motivational thinking. The total score was calculated to evaluate how thinking changed from baseline to 8 weeks and 12 weeks between the groups. Dolansky, M. A., et. al (2020).
Time frame: 8 Weeks
Personal Systems Thinking
20-item Systems Thinking Scale (adapted for patients) was totaled from a 5-point scale (Never, Seldom, Some of the time, Often, Most of the time). Range 20 (personal motivation) -100 (system level thinking). This survey assesses participants view of behavior from a personal (motivation) level to a system (environmental) level. This scale evaluates intervention to improve systems thinking away from a personal motivational thinking. The total score was calculated to evaluate how thinking changed from baseline to 8 weeks and 12 weeks between the groups. Dolansky, M. A., et. al (2020).
Time frame: 12 weeks