Dementia Research Consent Form

Dear participant,

We appreciate your decision to take part in this trial. The outcomes will not only benefit you and your loved ones but will also contribute to the well-being of future patients.

Participation in this clinical trial is entirely voluntary. You are encouraged to consult with your research doctor, any of our research doctors, your physician, as well as your family and friends before reaching a final decision on joining this clinical trial.

Kindly review this informed consent form thoroughly and then determine whether you would like to be a participant in this clinical trial.

Dementia is an enduring and advancing condition that has a significant impact on the lives of more than 7 million Americans. It poses considerable challenges to both mental and physical health. This research aims to explore a novel therapeutic approach that has the potential to enhance the quality of life for individuals with dementia and alleviate the burden on those who care for them. It is important to note that this study does not offer a cure, but the anticipated outcomes may contribute to an improved quality of life for dementia patients and potentially mitigate some of the behavioral and emotional distress associated with the progression of dementia.

I have extended invitations to a total of 140 individuals based on the analysis of the interest forms you submitted and the required group sizes.

The study involves two sequential steps. The initial step is the pre-study interview, which you are currently participating in. During this phase, you will sign a consent waiver, receive information about the study's structure, and complete a brief questionnaire identifying items you believe would evoke nostalgia in your loved one.

In the second step, your loved one will take part in the actual study. The session will commence with an assessment of cognition through a simple instructional task. If compliance is hindered by altered mental status, the date can be rescheduled for a more suitable time. Assuming compliance, I will proceed with the pre-test. This involves the participant viewing a series of images for 30 seconds, scrambling them, and then being tasked with restoring the original order within one minute. Subsequently, I will move on to the first sense, providing a 5-minute break before each subsequent trial. The procedure for each sense will mirror the pre-test, with the participant engaging in sensory stimulation for 3 minutes before reordering the presented images. A break will be offered after each trial.

I am exclusively evaluating a type of cognitive therapy. The participant will not be administered any medication or receive any medical care from me.
 
 
 

The findings of this research have the potential to enhance the quality of life for your loved one. Increased cognitive functioning and preserved memory could contribute to greater independence and a reduction in behavioral and emotional distress.

It is crucial to emphasize that this study is not a cure for dementia. There is a possibility that the study may not be effective for every participant, yielding limited positive results. Each participant is unique, and the aim is to assess these individual differences to formulate a personalized therapeutic plan.

The primary focus of this study is on improving the quality, not the quantity, of life.
 
 
 

I support the right to privacy for every individual, including yourself. I am committed to not disclosing your personal information to anyone under any circumstances. Any information utilized will be pertinent and strictly for the purpose of the study. Names, contact details, or addresses will not be revealed to anyone, even in the context of conclusions or journals. Your information will be kept strictly anonymous.

I have read the information above or it has been read to me and understand the purpose and of this clinical trial. I have had the opportunity to ask questions and by which all have been answered to my satisfaction. I give my consent to this clinical research and I voluntarily sign this informed consent to participate in this clinical trial.

I have read out to the participant accurately, the information sheet, and have explained to him/her to the best of my ability any concerns and benefits pertaining to this clinical trial. 

I confirm that the participant was given the opportunity to inquire about the clinical trial and that all questions were answered correctly and to the satisfaction of said participant. The participant was not in any way coerced, compelled, deceived into signing this consent, and that such consent was freely given by him/her voluntarily and freely.  

A copy of this Consent has been provided to the participant.