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.
Exclusion Criteria:
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.
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University of Göttingen