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Diet, ExerCIse and carDiovascular hEalth (DECIDE) - Salt Reduction Strategies for the Elderly in Nursing Homes in China (DECIDE-Salt)

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ClinicalTrials.gov Identifier: NCT03290716
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : June 11, 2021
Sponsor:
Collaborators:
Changzhi Medical College
Health Science Center of Xi'an Jiaotong University
Hohhot Center for Disease Control and Prevention
Yangcheng Ophthalmology Hospital
Information provided by (Responsible Party):
Yangfeng Wu, Peking University

Tracking Information
First Submitted Date  ICMJE September 5, 2017
First Posted Date  ICMJE September 25, 2017
Last Update Posted Date June 11, 2021
Actual Study Start Date  ICMJE September 25, 2017
Actual Primary Completion Date October 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2021)
The change in systolic blood pressure from baseline to follow-up [ Time Frame: baseline、6 month、12 month、18 month and 24-month follow-up ]
mmHg
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2017)
The change in systolic blood pressure [ Time Frame: baseline and 24-month follow-up ]
mmHg
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2021)
  • The incidence of hyperkalemia [ Time Frame: throughout 24 months of follow-up ]
    A new case of hyperkalemia is defined as having serum potassium >5.5 mmol/L at either month 12 or 24 among participants with normal serum potassium at the baseline, regardless of clinical manifestations.
  • The incidence of hypokalemia [ Time Frame: throughout 24 months of follow-up ]
    A new case of hypokalemia is defined as having serum potassium <3.5 mmol/L at either month 12 or 24 among participants with normal serum potassium at the baseline, regardless of clinical manifestations.
  • The change in 24-hour urinary sodium and potassium [ Time Frame: baseline and 24-month follow-up ]
    mmol/d
  • The change in 24-hour urinary microalbumin [ Time Frame: baseline and 24-month follow-up ]
    mg/day
  • The change in diastolic blood pressure from baseline to follow-up [ Time Frame: baseline、6 month、12 month、18 month and 24-month follow-up ]
    mmHg
  • ICER [ Time Frame: throughout 24 months of follow-up ]
    Incremental cost-effectiveness ratio, defined by the difference in the cost for every unit of gain in the pertained effectiveness outcome
  • Cardiovascular events [ Time Frame: throughout 24 months of follow-up ]
    fatal and nonfatal stroke, fatal and nonfatal myocardial infarction, hospitalization for congestive heart failure
  • Death [ Time Frame: throughout 24 months of follow-up ]
    all causes death
  • The incidence of hyponatremia [ Time Frame: throughout 24 months of follow-up ]
    A new case of hyponatremia is defined as having serum sodium <135 mmol/L at either 12 or 24 months with normal serum sodium at the baseline, regardless of clinical manifestations.
  • The incidence of renal dysfunction [ Time Frame: throughout 24 months of follow-up ]
    A new case of renal dysfunction is defined as having eGFR <60 at either 12 or 24 months with normal eGFR at the baseline, regardless of clinical manifestations.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2017)
  • The incidence of hyperkalemia [ Time Frame: throughout 24 months of follow-up ]
    total incidence cases of hyperkalemia identified among all nursing home residents
  • The change in 24-hour urinary sodium and potassium [ Time Frame: baseline and 24-month follow-up ]
    mmol/day
  • The change in 24-hour urinary microalbumin [ Time Frame: baseline and 24-month follow-up ]
    mg/day
  • The change in diastolic blood pressure [ Time Frame: baseline and 24-month follow-up ]
    mmHg
  • The change in ICER [ Time Frame: baseline and 24-month follow-up ]
    Incremental cost-effectiveness ratio (ICER) was estimated based on the observed effectiveness in lowering SBP.
  • Cardiovascular events [ Time Frame: throughout 24 months of follow-up ]
    all cardiovascular death and non-fatal myocardial infarction and stroke
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diet, ExerCIse and carDiovascular hEalth (DECIDE) - Salt Reduction Strategies for the Elderly in Nursing Homes in China
Official Title  ICMJE Diet, Exercise and Cardiovascular Health - Effect of Salt Substitute and Stepwise Salt Supply Control in Reducing Blood Pressure in the Elderly in Nursing Homes in China: a Factorial Cluster-randomized Controlled Trial
Brief Summary

The DECIDE - Salt in Elderly (Diet, ExerCIse and carDiovascular hEalth - Salt Reduction Strategies for the Elderly in Nursing Homes in China) is to evaluate the effects, safety and cost-effectiveness of salt substitution (SS) and stepwise salt supply control (SSSC) in reducing blood pressure in Chinese elderly in nursing homes. The study will recruit over 960 old people from 48 nursing homes in northern China. The 48 nursing homes will be randomised into the following 4 groups.

  1. salt substitute (SS) and stepwise salt supply control (SSSC);
  2. SS only;
  3. SSSC only; and
  4. no SS and no SSSC (control).

The intervention will last over 2 years. The randomization will be conducted centrally after the baseline survey completed. Primary outcome will be the change in systolic blood pressure. The secondary outcomes include: the changes in diastolic blood pressure, 24hr urinary sodium, potassium and microalbumin, and incidence of hyperkalemia, hypokalemia, hyponatremia, cardiovascular events, and all causes death, and incremental cost-effectiveness ratio.

Detailed Description

The DECIDE - Salt in Elderly (Diet, ExerCIse and carDiovascular hEalth - Salt Reduction Strategies for the Elderly in Nursing Homes in China) is a study in the DECIDE project, which includes five studies. The others are DECIDE - Diet, DECIDE - Exercise, DECIDE - Obesity in Children, and DECIDE - Smart Living. The DECIDE - Salt in Elderly study is to evaluate the effects, safety and cost-effectiveness of salt substitution (SS) and kitchen-based stepwise salt supply control (SSSC) in reducing blood pressure in Chinese elderly in nursing homes. Specifically, the study aims include:

  1. to test if a stepwise salt supply control strategy could significantly reduce systolic blood pressure among elderly living in nursing homes;
  2. to test if replacing regular salt with the market available salt substitute could significantly reduce systolic blood pressure among elderly living in nursing homes; and
  3. to test if the joint effect of the two strategies is larger than that from one of each.

The corresponding null hypotheses that will be tested are:

  1. the mean change from the baseline in systolic blood pressure of elderly residents in nursing homes that are supplied with SS is equal to the mean change from the baseline in systolic blood pressure of elderly residents in nursing homes that are supplied with regular salt;
  2. the mean change from the baseline in systolic blood pressure of elderly residents in nursing homes that apply SSSC is equal to the mean change from the baseline in systolic blood pressure of elderly residents in nursing homes that do not apply SSSC;
  3. There is no interaction between the two interventions above.

The study will recruit over 960 old people from 48 nursing homes in northern China, where the mean salt intake is generally higher than 12 g/day. A 2x2 factorial cluster-randomized trial will be used to test two independent salt reduction strategies: 1) using salt substitute to replace the regular salt in the kitchen of nursing homes; and 2) training the nursing manager to control/reduce, step by step, the amount of salt supplied to the kitchen of nursing homes. The 48 nursing homes will be randomized to the following 4 groups.

  1. salt substitute (SS) and stepwise salt supply control (SSSC);
  2. SS only;
  3. SSSC only; and
  4. no SS and no SSSC (control).

A brief health education on salt and health will be applied to all four groups. The salt substitute (NaCl 62.5% and KCl 25%) will be centrally provided. And the Train-the-trainers model will be used to train the nursing home managers how to implement the SSSC.

The intervention will last over 2 years. The baseline examination including three blood pressure measurements and one 24-hr urine collection will be conducted for all participants. Fasting blood samples will be drawn for measurement of serum potassium and detect hyperkalemia, hypokalemia, hyponatremia and renal dysfunction.

The randomization will be conducted centrally by the study coordinating center at Peking University Clinical Research Institute, after the baseline survey completed.

All participants will be followed up for blood pressure measurements at 6, 12, 18 and 24 months, for serum potassium at 12 and 24 months, and for 24-hr urine collection at 24 months.

Study outcomes:

Primary outcome: The change in systolic blood pressure from baseline to follow-up.

Secondary outcomes: The incidence of hyponatremia, hyperkalemia, hypokalemia and renal dysfunction from the baseline to 24 months. The change in 24-hr urinary sodium, potassium and microalbumin from the baseline to 24 months. The change in diastolic blood pressure from baseline to follow-up. The incremental cost-effectiveness ratio (ICER). The incidence of cardiovascular events and all causes death during follow up.

Power analysis:

On the assumptions of a 20% dropout rate, an intraclass correlation of 0.02, the number of clusters of 48 and at least 20 elderly people in each nursing home, and an α value of 0.05, the study to detect a mean 3.0 mmHg reduction in systolic blood pressure (SD, 18 mm Hg) between the intervention groups would have a power of 0.81. To detect a 4.0 mmHg reduction in systolic blood pressure (SD, 18 mm Hg), the power of the same sample size would be 0.96.

Statistical analysis: Linear models adjusted for clustering based on participants with available measures were used to assess continuous outcomes. Frailty survival models that account for clustering based upon all randomised participants were used for analysis of the effects on cardiovascular and mortality outcomes. Generalized linear mixed model were used for analysis of effects on hyperkalemia, hypokalemia, hyponatremia and renal dysfunction..

Ethical considerations:

The study will be submitted to and approved by the Peking University IRB, which has the full accreditation from AAHRRP. The study salt substitute is the product available on Chinese market and has been approved manufactured according to the product standards issued by the ministry of health. The SSSC approach will take every step for 3 months and the biggest step of salt reduction will be just 10% of the original amount of use. And the study will ensure an interview will be conducted to collect the feedback before every next step will take place. The SSSC intervention will stop at any time that elderly people feel unlike the foods.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Blood Pressure
Intervention  ICMJE
  • Other: SS
    Replace regular salt with market available potassium-enriched salt substitute in kitchens of nursing homes.
    Other Name: Salt substitution
  • Other: SSSC
    A stepwise approach to reduce salt used in the kitchen of nursing homes by controlling the supply of salt.
    Other Name: Stepwise salt supply control
Study Arms  ICMJE
  • Experimental: SS+SSSC
    Salt substitute plus stepwise salt supply control
    Interventions:
    • Other: SS
    • Other: SSSC
  • Experimental: SS only
    Salt substitute only
    Intervention: Other: SS
  • Experimental: SSSC only
    Stepwise salt supply control only
    Intervention: Other: SSSC
  • No Intervention: control
    No salt substitute and no stepwise salt supply control
Publications * Jin A, Zhao M, Sun Y, Feng X, Zhang R, Qiao Q, Wang H, Yuan J, Wang Y, Cheng L, Zhang H, Li HJ, Wu Y. Normal range of serum potassium, prevalence of dyskalaemia and associated factors in Chinese older adults: a cross-sectional study. BMJ Open. 2020 Oct 30;10(10):e039472. doi: 10.1136/bmjopen-2020-039472.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2021)
1612
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2017)
1080
Actual Study Completion Date  ICMJE May 11, 2021
Actual Primary Completion Date October 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Eligibility of nursing homes:

  • To be eligible, the nursing home must has not participated in any salt reduction or other intervention trials, has at least 20 residents and has agreed to participate in the study.

Eligibility of individual elderly:

Inclusion Criteria:

  • Living in the nursing home permanently or expectedly for the coming two years
  • Age less than 55 years.
  • Life expectancy over six months.
  • Provide written informed content.

Exclusion Criteria:

  • Clinically confirmed hyperkalemia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03290716
Other Study ID Numbers  ICMJE 2016YFC130020302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Yangfeng Wu, Peking University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Peking University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Changzhi Medical College
  • Health Science Center of Xi'an Jiaotong University
  • Hohhot Center for Disease Control and Prevention
  • Yangcheng Ophthalmology Hospital
Investigators  ICMJE
Principal Investigator: Yangfeng Wu, PhD Peking University
PRS Account Peking University
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP