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Trial record 2 of 30 for:    Recruiting, Not yet recruiting, Available Studies | "Intermittent Claudication"

Person-centered Follow up and Health Promotion Program After Revascularization for Intermittent Claudication (FASTIC)

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ClinicalTrials.gov Identifier: NCT03283358
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Anneli Linné, Karolinska Institutet

Brief Summary:
The overall aim of the study is to evaluate a nurse-led intervention (person-centered follow up and health promotion) program in comparison to standard follow up for patients treated with surgical or endovascular revascularization of Intermittent Claudication.

Condition or disease Intervention/treatment Phase
Intermittent Claudication Behavioral: Person-centered follow up Not Applicable

Detailed Description:

Specific Aims:

  1. To evaluate the effect of the intervention program on patient's adherence to medication (anticoagulant agents, antiplatelet agents and lipid-lowering agents), risk modification and surgical treatment outcomes
  2. To investigate the effect of the intervention program on patient reported outcomes
  3. To investigate the effect of the intervention program on patient reported experiences
  4. To investigate the long-term effect of the intervention program on mortality, cause of death, occurrence/recurrence of cardiovascular disease up to 10 years after the surgical/endovascular treatment
  5. To compare patient-reported adherence to medication and patient data registry adherence to medication

Hypothesis: Participants in the Intervention Group have better adherence to prescribed medication and a reduced risk for 10-year predicted coronary heart disease (CHD) compared to participants in the Control Group.

Study population:

Patients with Intermittent Claudication scheduled for revascularization, through open surgery or endovascular method, in Stockholm will be screened for inclusion. After informed consent, the participants will be randomized to either Intervention Group or Control Group. Those participants who couldn't receive revascularization after giving consent will be withdrawn from the study and counted as drop outs. Power analysis has showed a required sample size of 186 participants to detect a statistically significant increase in adherence to medication from 50% to 70% (power 0.80, significance value 0.05, two-sided). Expecting 10% drop-out we plan to recruit 210 participants.

Data collection:

Data on primary and secondary outcomes, serum cholesterol, smoking status, serum carbon monoxide, Hba1c, BMI, waist circumference, physical exercise, diet, alcohol consumption, graft patency, re-intervention, hospitalization during the study year, mortality and patient characteristics/demographics will be collected at baseline and one year after treatment. All data will be registered at a local research data base at Karolinska Institutet. All patient-reported outcomes will be collected using web-based questionnaires linked to the data base.

Data analysis:

Comparisons between the Intervention Group and the Control Group will be made using t-test and ANOVA for repeated-measures or Wilcoxon rank-signed test and Kruskall-Wallis according to the underlying distribution for continuous data, and Fischers Exact test for categorical data. Logistic regression analysis will also be performed to adjust for confounding factors. All analyses will be performed according to the Intention-to-treat principle.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Person-centered Follow up and Health Promotion Program After Revascularization for Intermittent Claudication
Actual Study Start Date : June 13, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Person-centered follow up
The intervention program is a person-centered health promotion program led by a nurse and consists of two telephone calls (15 minutes each) at two weeks and nine months after surgical treatment for Intermittent Claudication and three visits (45 - 60 min) at six weeks, six months and one year after treatment. The program includes a baseline assessment, an individual plan for self-care and educational information about Intermittent Claudication, received treatment and secondary prevention (medication and modifiable risk factors). The purpose is to enhance self-care in terms of adherence to medication and to recommended changes of lifestyle.
Behavioral: Person-centered follow up
No Intervention: Standard follow up
Standard follow-up consist of two follow up appointments á 20 minutes at four-six weeks and one year after surgical treatment of Intermittent Claudication. The patients meet a vascular surgeon at the first follow up and a vascular nurse or a surgeon at the second follow up visit.



Primary Outcome Measures :
  1. Adherence to medication [ Time Frame: One year after surgical or endovascular treatment for Intermittent Claudication ]
    Adherence to medication (anticoagulant agents, antiplatelet agents and lipid-lowering agents) according to the Swedish Prescribed Drug Registry (PDR). dispensed anticoagulant agents, antiplatelet agents (ATC-register B01A) and lipid-lowering agents (ATC-register C10). Those participants who have fetched both medications for the second refill after treatment will be considered adherent.


Secondary Outcome Measures :
  1. Risk for 10-year predicted coronary heart disease (CHD) [ Time Frame: One year after surgical or endovascular treatment for Intermittent Claudication ]
    Changes in risk for CHD within 10-years measured by Framingham Risk Score (FRHS).


Other Outcome Measures:
  1. Patient reported adherence to medication [ Time Frame: One year after surgical or endovascular treatment for Intermittent Claudication ]
    Patient-reported adherence to medication according to Morisky Medication Adherence Scale (MMAS-8)

  2. Generic Health-related Quality of Life (HRQOL) [ Time Frame: One year after surgical or endovascular treatment for Intermittent Claudication ]
    Patient-reported generic HrQoL measured by EQ-5D

  3. Condition specific Health-related Quality of Life (HRQOL) [ Time Frame: One year after surgical or endovascular treatment for Intermittent Claudication ]
    Patient-reported specific HrQoL measured by VascQol-6

  4. Beliefs on medication [ Time Frame: One year after surgical or endovascular treatment for Intermittent Claudication ]
    Patient-reported beliefs on medication measured by Beliefs about Meicines Questionnaire (BMQ)

  5. Self-efficacy [ Time Frame: One year after surgical or endovascular treatment for Intermittent Claudication ]
    Patient-reported Self-efficacy measured by Swedish Version of the General Self-Efficacy Scale

  6. Health literacy [ Time Frame: One year after surgical or endovascular treatment for Intermittent Claudication ]
    Patient-reported health literacy measured by HLS-EU-Q16 SE

  7. Patient-experienced quality of care [ Time Frame: One year after surgical or endovascular treatment for Intermittent Claudication ]
    Patient-experienced quality of care measured by Quality of Care from Patient's Perspective (Swedish version of QPP)

  8. Mortality [ Time Frame: Ten years after surgical or endovascular treatment for Intermittent Claudication ]
    Data on mortality will be extracted from the National Patient Registry and Stockholm County Council's administrative data (VårdanalysdataLager - VAL).

  9. Cardiovascular disease [ Time Frame: Ten years after surgical or endovascular treatment for Intermittent Claudication ]
    Data on occurrence/reoccurrence of cardiovascular disease with hospitalization will be extracted from the National Patient Registry and Stockholm County Council's administrative data (VårdanalysdataLager - VAL).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients who is scheduled for revascularization, through open and/or endovascular surgery for IC diagnosed according to Diagnosis Related Group (DRG) with I70.2 or I739B

Exclusion Criteria:

  • Patients not treated through surgery or revascularization
  • Patients diagnosed with dementia
  • Patients discharge to a nursery home,
  • Patients not accountable for administrating their own medications
  • Patients with a survival expectancy less than one year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283358


Contacts
Contact: Eva Joelsson-Alm, RN, PhD +46 8 6162929 eva.joelsson-alm@ki.se
Contact: Sara Haile, RN +46 8 6162462 sara.haile@sodersjukhuset.se

Locations
Sweden
Department of Surgery, Unit of Vascular Surgery, Södersjukhuset Recruiting
Stockholm, Sweden, SE-11883
Contact: Sara Haile, RN    +46 8 6162462    sara.haile@sodersjukhuset.se   
Principal Investigator: Anneli Linné, MD, PhD         
Karolinska University Hospital, Dept of Vascular Surgery Recruiting
Stockholm, Sweden
Contact: Ulrika Palmer Kazen, MD, PhD    08-51770000      
Principal Investigator: Ulrika Palmer Kazen, MD, PhD         
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Anneli Linné, MD, PhD Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset, Stockholm, Sweden

Responsible Party: Anneli Linné, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03283358     History of Changes
Other Study ID Numbers: FASTIC-1
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Anneli Linné, Karolinska Institutet:
Prevention and control

Additional relevant MeSH terms:
Intermittent Claudication
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms