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A Patient-Spouse Intervention for Self-Managing High Cholesterol (CouPLES)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00321789
First received: May 3, 2006
Last updated: April 6, 2015
Last verified: August 2014
Results First Received: September 2, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor)
Condition: Hypercholesterolemia
Intervention: Behavioral: spouse-assisted intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intervention Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
Usual Care Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.

Participant Flow:   Overall Study
    Intervention   Usual Care
STARTED   127   128 
COMPLETED   112   112 
NOT COMPLETED   15   16 
Lost to Follow-up                4                7 
Withdrawal by Subject                6                6 
Protocol Violation                5                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intervention Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
Usual Care Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
Total Total of all reporting groups

Baseline Measures
   Intervention   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 127   128   255 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.7  (12.3)   61.0  (12.2)   61.3  (12.3) 
Gender 
[Units: Participants]
     
Female   10   3   13 
Male   117   125   242 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   1   1   2 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   35   43   78 
White   82   81   163 
More than one race   0   0   0 
Unknown or Not Reported   9   3   12 
Region of Enrollment 
[Units: Participants]
     
United States   127   128   255 
Education 
[Units: Participants]
     
8th grade or less   2   2   4 
some high school   4   6   10 
high school degree or equivalent   26   20   46 
some college or vocational training, no degree   34   35   69 
Associate's degree   23   21   44 
Bachelor's degree   19   28   47 
Graduate or professional degree   16   15   31 
not reported   3   1   4 
Employment status 
[Units: Participants]
     
working full time   46   58   104 
working part time   19   10   29 
unemployed, searching for work   5   5   10 
unemployed, not searching for work   3   2   5 
retired   43   47   90 
disabled   8   5   13 
not reported   3   1   4 
High risk for cardiovascular event based on Framingham score 
[Units: Participants]
     
high risk   25   19   44 
low or moderate risk   102   109   211 
number of participants who met goal for low-density lipoprotein cholesterol at baseline [1] 
[Units: Participants]
     
met goal   45   62   107 
did not meet goal   82   66   148 
[1] Goal is determined by 2003 National Cholesterol Education Program guidelines. Goal could be 160mg/dL for low risk (no coronary heart disease (CHD), 0-1 risk factor); 130 mg/dL for medium risk (no CHD, at least 2 risk factors); or 100 mg/dL for high risk (CHD and risk equivalents including diabetes, atherosclerotic disease, and multiple risk factors that confer a 10-year risk for CHD >20% per Framingham score).
number of participants prescribed cholesterol medication at baseline 
[Units: Participants]
     
taking cholesterol medication   62   57   119 
not taking cholesterol medication   65   71   136 
Missed at least one dose of cholesterol medication in previous 30 days at baseline [1] 
[Units: Participants]
     
missed at least one dose   31   28   59 
did not miss at least one dose   31   29   60 
not relevant (not taking medication)   65   71   136 
[1] Based on self-report to a single item querying whether participants missed doses in the previous 30 days.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Low-density Lipoprotein Cholesterol   [ Time Frame: 11-month follow-up ]

2.  Secondary:   Caloric Intake   [ Time Frame: 11-month follow-up ]

3.  Secondary:   Saturated Fat (Grams/Day)   [ Time Frame: 11-month follow-up ]

4.  Secondary:   Total Fat (Grams/Day)   [ Time Frame: 11-month follow-up ]

5.  Secondary:   Cholesterol Intake   [ Time Frame: 11-month follow-up ]

6.  Secondary:   Fiber Intake   [ Time Frame: 11-month follow-up ]

7.  Secondary:   Frequency of Moderate Intensity Physical Activity   [ Time Frame: 11-month follow-up ]

8.  Secondary:   Duration of Moderate Intensity Physical Activity   [ Time Frame: 11-month follow-up ]

9.  Secondary:   Total Fat (%)   [ Time Frame: 11-month follow-up ]

10.  Secondary:   Saturated Fat (%)   [ Time Frame: 11-month follow-up ]

11.  Secondary:   Number of Participants With Goal LDL-C   [ Time Frame: 11-month follow-up ]

12.  Secondary:   Number of Participants Prescribed Cholesterol Medication   [ Time Frame: 11-month follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The dietary measure underestimates dietary intake but should not invalidate differences between groups or across time. Sample size for dietary analyses was reduced due to missing data, but non-responders did not differ on measured characteristics.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Corrine I. Voils
Organization: Veterans Affairs Medical Center
phone: 919-286-0411 ext 5196
e-mail: corrine.voils@va.gov


Publications of Results:


Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00321789     History of Changes
Other Study ID Numbers: IIR 05-273
Study First Received: May 3, 2006
Results First Received: September 2, 2014
Last Updated: April 6, 2015