Establishing the Feasibility of a Tablet-Based Consent Process with Older Adults: A Mixed-Methods Study

Purpose of the Study This mixed-methods study explored the feasibility and acceptability of using a tablet-based research consent process with adults aged ≥65 years. Design and Methods In the first phase, focus group participants reported on their perceptions of a tablet-based consent process. In the second phase, older adults were randomized to view either a tablet-based or paper-based consent for a mock clinical trial. Measurements included: time to complete, adverse/unexpected events, user-friendliness, immediate comprehension, and retention at a 1-week delay. Results Focus group participants (N = 15) expressed interest in the novel format, cautioning that peers would need comprehensive orientation to use the technology. In the randomized pilot (N = 20), retention was 100% and all participants completed the protocol without the occurrence of adverse/unexpected events. Although the participants took longer to complete the tablet-based consent than the paper-based version, user-friendliness, immediate comprehension, and retention of the tablet-based consent were similar to the paper-based consent. Discussion and Implications The findings suggest that a tablet-based consent process is feasible to implement with older adults and acceptable to this population, but we would underscore that efforts to optimize design of tablet-based consent forms for older adults are warranted.

[1]  T. Perneger,et al.  Patient-reported conformity of informed consent procedures and participation in clinical research. , 2011, QJM : monthly journal of the Association of Physicians.

[2]  Measuring Attitudes Toward Participation in Cancer Treatment and Cancer Prevention Trials: The Attitudes Toward Cancer Trials Scales (ACTS) , 2008, Journal of Nursing Measurement.

[3]  C. Suver,et al.  Formative Evaluation of Participant Experience With Mobile eConsent in the App-Mediated Parkinson mPower Study: A Mixed Methods Study , 2017, JMIR mHealth and uHealth.

[4]  M. Folstein,et al.  Mini‐Mental State Examination , 2014 .

[5]  Aaron C. T. Smith Older adults and technology use , 2014 .

[6]  D C McCrory,et al.  Getting Meaningful Informed Consent from Older Adults: A Structured Literature Review of Empirical Research , 1998, Journal of the American Geriatrics Society.

[7]  A. Culyer Disabilities of the Arm, Shoulder and Hand , 2014 .

[8]  R. Spitzer,et al.  Patient Health Questionnaire-9 , 2011 .

[9]  Mariam Adawiah Dzulkifli,et al.  The influence of colour on memory performance: a review. , 2013, The Malaysian journal of medical sciences : MJMS.

[10]  Rebecca Ryan,et al.  Audio-visual presentation of information for informed consent for participation in clinical trials. , 2008, The Cochrane database of systematic reviews.

[11]  L. Yardley,et al.  Development and initial validation of the Falls Efficacy Scale-International (FES-I). , 2005, Age and ageing.

[12]  R. Marioni,et al.  Age-associated cognitive decline. , 2009, British medical bulletin.

[13]  F. Bloch,et al.  Attitudes of Older Adults to Their Participation in Clinical Trials: A Pilot Study , 2014, Drugs & Aging.

[14]  Steven A. Julious,et al.  Sample size of 12 per group rule of thumb for a pilot study , 2005 .

[15]  Terri Voepel-Lewis,et al.  Digital multimedia: a new approach for informed consent? , 2015, JAMA.

[16]  C. Macintyre,et al.  Difficulties in recruiting older people in clinical trials: an examination of barriers and solutions. , 2010, Vaccine.

[17]  Sara Haber,et al.  Training Older Adults to Use Tablet Computers: Does It Enhance Cognitive Function? , 2014, The Gerontologist.

[18]  Joanne R. Nurss,et al.  Test of Functional Health Literacy in Adults , 2016 .

[19]  T. Becker,et al.  Informed consent and research subject understanding of clinical trials. , 2013, WMJ : official publication of the State Medical Society of Wisconsin.

[20]  Réjean Hébert,et al.  Age-related changes in upper extremity performance of elderly people: a longitudinal study , 1999, Experimental Gerontology.

[21]  Charles D. Spielberger,et al.  State-Trait Anxiety Inventory and State-Trait Anger Expression Inventory. , 1994 .

[22]  Elena Springall,et al.  A systematic review of factors influencing older adults' decision to accept or decline cancer treatment. , 2015, Cancer treatment reviews.

[23]  D. Goldberg,et al.  Disparate inclusion of older adults in clinical trials: priorities and opportunities for policy and practice change. , 2010, American journal of public health.

[24]  Sara West Bechtold,et al.  The Cognitive Theory of Multimedia Learning: The Impact of Social Cues , 2017 .

[25]  K. Cook,et al.  Effect of social support on informed consent in older adults with Parkinson disease and their caregivers , 2007, Journal of Medical Ethics.

[26]  Y. Hsieh,et al.  Informed consent for opt-in HIV testing via tablet kiosk: an assessment of patient comprehension and acceptability , 2017, International journal of STD & AIDS.

[27]  M. Fine,et al.  The impact of iMedConsent on patient decision-making regarding cholecystectomy and inguinal herniorrhaphy. , 2012, The Journal of surgical research.

[28]  Riddle Dr,et al.  Changes in Cognitive Function in Human Aging -- Brain Aging: Models, Methods, and Mechanisms , 2007 .

[29]  Rick A Adams,et al.  Risk Taking for Potential Reward Decreases across the Lifespan , 2016, Current Biology.

[30]  M. Daneman,et al.  Age-Related Changes in Reading Comprehension: An Individual-Differences Perspective , 2009, Experimental aging research.

[31]  S. Eckstein The Belmont Report: ethical principles and guidelines for the protection of human subjects of research , 2003 .

[32]  R. Heinssen,et al.  Assessing computer anxiety: Development and validation of the Computer Anxiety Rating Scale , 1987 .

[33]  James Flory,et al.  Interventions to improve research participants' understanding in informed consent for research: a systematic review. , 2004, JAMA.

[34]  Wanda Montalvo,et al.  Participant comprehension of research for which they volunteer: a systematic review. , 2014, Journal of nursing scholarship : an official publication of Sigma Theta Tau International Honor Society of Nursing.

[35]  P. Tun,et al.  The effects of aging on auditory processing and cognition. , 2012, American journal of audiology.

[36]  E. Glisky Changes in Cognitive Function in Human Aging , 2007 .

[37]  C. Glenton,et al.  What about N? A methodological study of sample-size reporting in focus group studies , 2011, BMC medical research methodology.

[38]  S. Cummings,et al.  Interactive Informed Consent: Randomized Comparison with Paper Consents , 2013, PloS one.

[39]  E. McAuley,et al.  A Comparison of Tablet Computer and Paper-Based Questionnaires in Healthy Aging Research , 2014, JMIR research protocols.

[40]  Michael P Caligiuri,et al.  Reformed consent: adapting to new media and research participant preferences. , 2009, IRB.

[41]  Christiane,et al.  WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI: Ethical Principles for Medical Research Involving Human Subjects , 2001, Journal of postgraduate medicine.

[42]  H. Kraemer,et al.  A new brief instrument for assessing decisional capacity for clinical research. , 2007, Archives of general psychiatry.

[43]  Gislin Dagnelie Age-related psychophysical changes and low vision. , 2013, Investigative ophthalmology & visual science.

[44]  Wolzt,et al.  World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. , 2003, The Journal of the American College of Dentists.

[45]  Hsiu-Fang Hsieh,et al.  Three Approaches to Qualitative Content Analysis , 2005, Qualitative health research.

[46]  Nadine Bol,et al.  The Effect of Modality and Narration Style on Recall of Online Health Information: Results From a Web-Based Experiment , 2015, Journal of medical Internet research.

[47]  D. Jeste,et al.  Effectiveness of multimedia aids to enhance comprehension of research consent information: a systematic review. , 2012, IRB.