MedDataX Logo

Trial Outcomes & Findings for OxCKD1 -Empowering Healthy Lifestyle Choices in Chronic Kidney Disease (NCT NCT01552317)

NCT ID: NCT01552317

Last Updated: 2024-08-19

Results Overview

To evaluate whether a new care bundle helps patients to reduce their salt intake.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

201 participants

Primary outcome timeframe

1 month

Results posted on

2024-08-19

Participant Flow

Note. 201 participants were enrolled into the study following informed consent. Following informed consent, there was a 1-month period of normal routine care after which participants reattended and were randomized to the intervention or to normal routine care (the control group). Only 193 participants attended for randomization.

Participant milestones

Participant milestones
Measure
Intervention
A package of advice and interventions to help participants reduce their salt intake. OxSalt care bundle: A care bundle consisting of a range of features to help patients to reduce their salt intake such as reminder emails, phone calls and a website.
Normal Care
This group will receive the normal care that they would get anyway.
Overall Study
STARTED
96
97
Overall Study
COMPLETED
77
81
Overall Study
NOT COMPLETED
19
16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

OxCKD1 -Empowering Healthy Lifestyle Choices in Chronic Kidney Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention
n=96 Participants
A package of advice and interventions to help participants reduce their salt intake. OxSalt care bundle: A care bundle consisting of a range of features to help patients to reduce their salt intake such as reminder emails, phone calls and a website.
Normal Care
n=97 Participants
This group will receive the normal care that they would get anyway.
Total
n=193 Participants
Total of all reporting groups
Age, Continuous
63.3 years
STANDARD_DEVIATION 12.8 • n=5 Participants
64.2 years
STANDARD_DEVIATION 10.5 • n=7 Participants
63.7 years
STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male
Female
49 Participants
n=5 Participants
48 Participants
n=7 Participants
97 Participants
n=5 Participants
Sex: Female, Male
Male
47 Participants
n=5 Participants
49 Participants
n=7 Participants
96 Participants
n=5 Participants
Race/Ethnicity, Customized
African
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Race/Ethnicity, Customized
Any other Asian background
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Any other ethnic group
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Any other mixed background
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race/Ethnicity, Customized
Any other White background
5 Participants
n=5 Participants
3 Participants
n=7 Participants
8 Participants
n=5 Participants
Race/Ethnicity, Customized
British
84 Participants
n=5 Participants
86 Participants
n=7 Participants
170 Participants
n=5 Participants
Race/Ethnicity, Customized
Caribbean
0 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
Race/Ethnicity, Customized
Irish
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Race/Ethnicity, Customized
Pakistani
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
White and Asian
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
White and Black African
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Region of Enrollment
United Kingdom
96 participants
n=5 Participants
97 participants
n=7 Participants
193 participants
n=5 Participants
24-hour urinary sodium excretion
125 mmol/day
STANDARD_DEVIATION 53 • n=5 Participants
134 mmol/day
STANDARD_DEVIATION 58 • n=7 Participants
129 mmol/day
STANDARD_DEVIATION 56 • n=5 Participants
24-hour urinary salt excretion
7.3 grams/ day
STANDARD_DEVIATION 3.1 • n=5 Participants
7.8 grams/ day
STANDARD_DEVIATION 3.4 • n=7 Participants
7.6 grams/ day
STANDARD_DEVIATION 3.3 • n=5 Participants

PRIMARY outcome

Timeframe: 1 month

To evaluate whether a new care bundle helps patients to reduce their salt intake.

Outcome measures

Outcome measures
Measure
Intervention
n=77 Participants
A package of advice and interventions to help participants reduce their salt intake. OxSalt care bundle: A care bundle consisting of a range of features to help patients to reduce their salt intake such as reminder emails, phone calls and a website.
Normal Care
n=81 Participants
This group will receive the normal care that they would get anyway.
24-hour Urinary Sodium Excretion
93 mmol/day
Standard Deviation 48
119 mmol/day
Standard Deviation 52

PRIMARY outcome

Timeframe: 1 month

Outcome measures

Outcome measures
Measure
Intervention
n=77 Participants
A package of advice and interventions to help participants reduce their salt intake. OxSalt care bundle: A care bundle consisting of a range of features to help patients to reduce their salt intake such as reminder emails, phone calls and a website.
Normal Care
n=81 Participants
This group will receive the normal care that they would get anyway.
24-hour Urinary Salt Excretion
5.4 grams/ day
Standard Deviation 2.8
6.9 grams/ day
Standard Deviation 3.1

SECONDARY outcome

Timeframe: 3 months

Population: The primary study period was 1 month after randomization to the intervention or to normal routine care (the control group). Participants were invited to further assessment 3 months following randomization and 69 in the control group and 65 in the intervention group undertook this.

Outcome measures

Outcome measures
Measure
Intervention
n=65 Participants
A package of advice and interventions to help participants reduce their salt intake. OxSalt care bundle: A care bundle consisting of a range of features to help patients to reduce their salt intake such as reminder emails, phone calls and a website.
Normal Care
n=69 Participants
This group will receive the normal care that they would get anyway.
24-hour Urinary Sodium Excretion
100 mmol/day
Standard Deviation 41
113 mmol/day
Standard Deviation 52

SECONDARY outcome

Timeframe: 3 months

Population: The primary study period was 1 month after randomization to the intervention or to normal routine care (the control group). Participants were invited to further assessment 3 months following randomization and 69 in the control group and 65 in the intervention group undertook this.

Outcome measures

Outcome measures
Measure
Intervention
n=65 Participants
A package of advice and interventions to help participants reduce their salt intake. OxSalt care bundle: A care bundle consisting of a range of features to help patients to reduce their salt intake such as reminder emails, phone calls and a website.
Normal Care
n=69 Participants
This group will receive the normal care that they would get anyway.
24-hour Urinary Salt Excretion
5.9 grams/ day
Standard Deviation 2.4
6.6 grams/ day
Standard Deviation 3.1

SECONDARY outcome

Timeframe: 11 months

Population: The primary study period was 1 month after randomization to the intervention or to normal routine care (the control group). Participants were invited to further assessment 11 months following randomization and 16 in the control group and 44 in the intervention group undertook this.

Outcome measures

Outcome measures
Measure
Intervention
n=44 Participants
A package of advice and interventions to help participants reduce their salt intake. OxSalt care bundle: A care bundle consisting of a range of features to help patients to reduce their salt intake such as reminder emails, phone calls and a website.
Normal Care
n=16 Participants
This group will receive the normal care that they would get anyway.
24-hour Urinary Sodium Excretion
106 mmol/day
Standard Deviation 41
121 mmol/day
Standard Deviation 58

SECONDARY outcome

Timeframe: 11 months

Population: The primary study period was 1 month after randomization to the intervention or to normal routine care (the control group). Participants were invited to further assessment 11 months following randomization and 16 in the control group and 44 in the intervention group undertook this.

Outcome measures

Outcome measures
Measure
Intervention
n=44 Participants
A package of advice and interventions to help participants reduce their salt intake. OxSalt care bundle: A care bundle consisting of a range of features to help patients to reduce their salt intake such as reminder emails, phone calls and a website.
Normal Care
n=16 Participants
This group will receive the normal care that they would get anyway.
24-hour Urinary Salt Excretion
6.2 grams/ day
Standard Deviation 2.4
7.1 grams/ day
Standard Deviation 3.4

Adverse Events

Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Normal Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

University of Oxford

Phone: +441865287794

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place