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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00321789
First received: May 3, 2006
Last updated: September 25, 2014
Last verified: September 2014
Results First Received: September 2, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (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  
Number of Participants  
[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  
Study-Specific Measure  
[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  
Study-Specific Measure  
[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  
Study-Specific Measure  
[units: participants]
     
high risk     25     19     44  
low or moderate risk     102     109     211  
Study-Specific Measure [1]
[units: participants]
     
met goal     45     62     107  
did not meet goal     82     66     148  
Study-Specific Measure  
[units: participants]
     
taking cholesterol medication     62     57     119  
not taking cholesterol medication     65     71     136  
Study-Specific Measure [2]
[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] 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).
[2] Based on self-report to a single item querying whether participants missed doses in the previous 30 days.



  Outcome Measures
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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: Department of Veterans Affairs
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: September 25, 2014
Health Authority: United States: Federal Government