An interventional study of Motivational interviewing in Diastolic Heart Failure, sponsored by University of Göttingen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-18.
Sponsored by University of Göttingen · Not applicable, Interventional, and Supportive care
The aim of our pilot study is to evaluate the feasibility, acceptance and efficacy of motivational interviewing (MI) to support elderly patients with heart failure with preserved ejection fraction (HFpEF) in maintaining or starting physical activity (PA).
Patients discharged from the Ex-DHF trial were recruited from June 2013 to December 2015 and offered participation in a controlled add-on pilot study. The treatment group (n=19) received 5 sessions of MI, each lasting 15-30 min over 6 months to enhance physical activity.
For the first two and the last sessions participants met with the psychologist-counsellor face-to-face for about 45 minutes. The remaining three sessions could be conducted via telephone or face-to-face, depending on participants' preferences, and typically lasted 15-30 minutes. Per study protocol, counsellors (physicians and psychologists trained in motivational interviewing) assisted the participants in: (1) Setting goals for their physical activity; (2) developing a plan to increase physical activities; (3) setting specific plans for the implementation of the plan; and (4) overcoming possible barriers. Participants were also asked to keep track of their daily physical activity in a diary, which counsellors then discussed with them during the sessions.
After patients had given their written informed consent, counsellors assessed all participants via structured interview and self-rating scales. At baseline only, sociodemographic information was recorded.
At baseline and at the final 6-month visit participants' motivation to be physically active in the upcoming weeks was assessed using the SSK-scale ("Sportbezogene Selbstkonkord" = sports-related self-concordance, Seelig and Fuchs 2006) to assess the self concordance of sport- and exercise-related goals.
The kind and extent of patients' daily physical activity was recorded using patient diaries. At baseline and 6 months we also conducted a symptom-limited cardiopulmonary exercise test on a bicycle ergometer, in order to assess changes in maximum rate of oxygen consumption during the last 30 seconds before the termination of the exercise (peak oxygen consumption (VO2 [ml/min/kg])) as measure of maximal exercise capacity. Participants also completed the 6-minute walk test on flat surface (6-MWT) as an additional parameter to assess submaximal exercise capacity.
Additionally, at the 6-month assessment, intervention participants filled out a questionnaire about their subjective evaluation of the counseling program.
The control group (n=20) received usual care.
199 studies on the registry are indexed under Heart Failure, Diastolic; 44 are open to participants now.
This study's enrollment of 39 is below the median of 48 across 139 interventional studies indexed under Heart Failure, Diastolic.
Browse Heart Failure, Diastolic studies →University of Göttingen is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Over a time span of 6 months, participants in the intervention group received up to 7 sessions of motivational counseling, lasting 15-30 minutes each, to enhance physical activity.
Behavioral: Motivational interviewing
Participants who served as controls received usual care.
Adherence to intervention
To evaluate the feasibility of motivational counseling to enhance physical activity patients´ adherence to appointments is assessed as number / percentage of sessions attended
Time frame: Over 6 month intervention period
Patient acceptance of intervention
To assess how patients evaluate the Intervention, i.e. receiving motivational counseling, they were asked to fill in evaluation sheets
Time frame: At 6-month assessment
Effectiveness (peak VO2)
Changes in the maximal exercise capacity (peak VO2) during a symptom-limited cardiopulmonary exercise test on a bicycle ergometer.
Time frame: Change from baseline to 6-month assessment
Effectiveness (6-minute walk distance)
Six-minutes walking distance
Time frame: Change from baseline to 6-month assessment
Motivation
Participants' motivation to be physically active was registered using the SSK (Sports-related self-concordance) scale. The self-concordance score is computed by subtracting the sum of the introjected and extrinsic motivation from the sum of the intrinsic and identified motivation subscales, with resulting scores ranging from -10 to +10 (higher value = higher self-concordance)
Time frame: Change from baseline to 6-month assessment.
Physical activity
The kind and extent of patients' daily physical activity was recorded using patient diaries
Time frame: Change from baseline to 6-month assessment.
No study locations are listed for this record.
Ran from Jun 2013 to primary completion in Dec 2015, 29 months.
Of 39 non-industry interventional studies with no phase under Heart Failure, Diastolic, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 57. This study's 29 months is below that.
Counting every sponsor, half of 45 studies reached it within 48 months; a quarter within 26 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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University of Göttingen